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FDA Approves First in Class Tx for Myelosuppression in SCLC – Cosela

Earlier this month the FDA approved another infused specialty therapy, Cosela (trilaciclib) from G1 Therapeutics. It is the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer (when the cancer has spread beyond the lungs).

Cosela is to be used as a protective agent against bone marrow loss among adults before chemotherapy regimens that contain a platinum agent/etoposide or topotecan for extensive-stage small cell lung cancer. Previous treatments that address bone marrow injury have only attempted to remedy it after the fact.

The American Cancer Society estimates for all types of lung cancer in the United States for 2021 are:
~235,000 new cases of lung cancer (119,100 in men and 116,660 in women)
~131,000 deaths from lung cancer (69,410 in men and 62,470 in women)
Small Cell Lung Cancer represents ~20%+ of new cases or ~50,000 new cases annually

Cosela will hit the market at a wholesale acquisition cost of $1,471 per vial, and a full treatment will cost about $34,000 per patient on average.

Distribution details were not released by G1 Therapeutics. Given the fairly large eligible patient population and ‘relatively’ low price, it is unlikely that this new specialty therapy will be handled through specialty pharmacy distribution.

FDA Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy
Drug Is Given Before Chemotherapy to Protect Bone Marrow Function

February 12, 2021 — Today, the U.S. Food and Drug Administration approved Cosela (trilaciclib) to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving chemotherapy for extensive-stage small cell lung cancer. Cosela may help protect bone marrow cells from damage caused by chemotherapy by inhibiting cyclin- dependent kinase 4/6, a type of enzyme.

“For patients with extensive-stage small cell lung cancer, protecting bone marrow function may help make their chemotherapy safer and allow them to complete their course of treatment on time and according to plan,” said Albert Deisseroth, M.D., Ph.D., supervisory medical officer in the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Cosela will give patients a treatment option that can reduce the occurrence of a common, harmful side effect of chemotherapy.”

Chemotherapy drugs are designed to kill cancer cells but can damage normal tissues as well. The bone marrow is particularly susceptible to chemotherapy damage. The bone marrow makes red blood cells, white blood cells, and platelets (small fragments in the blood) that transport oxygen, fight infection, and stop bleeding.

The effectiveness of Cosela was evaluated in three randomized, double-blind, placebo-controlled studies in patients with extensive-stage small cell lung cancer. Combined, these studies randomly assigned 245 patients to receive either an infusion of Cosela in their veins or a placebo before chemotherapy. The studies then compared the two groups for the proportion of patients with severe neutropenia (a very low count of white blood cells called neutrophils) and the duration of severe neutropenia in the first cycle of chemotherapy. In all three studies, patients who received Cosela had a lower chance of having severe neutropenia compared to patients who received a placebo. Among those who had severe neutropenia, patients who received Cosela, on average, had it for a shorter time than patients who received a placebo.

The most common side effects of Cosela include fatigue; low levels of calcium, potassium and phosphate; increased levels of an enzyme called aspartate aminotransferase; headache; and infection in the lungs (pneumonia).

Patients should also be advised about injection site reactions, acute drug hypersensitivity, interstitial lung disease/pneumonitis (lung tissue inflammation) and embryo-fetal toxicity.

Cosela received FDA Priority Review and Breakthrough Therapy designations for the indication noted above.

The FDA granted the approval of Cosela to G1 Therapeutics, Inc.


Dosing Schedule Adjustments for Patients Receiving Vaccine

As readers of the AntonRx Report may know, we scan hundreds of articles each week to sleuth out information that is timely and important to specialty pharmacies. Earlier this week we ran across the first article we’ve seen that directly addresses Covid 19 and the specific impact to patients on a specialty therapy, in this case Rheumatoid Arthritis.

The article is a bit lengthy but offers a template for any specialty pharmacy to develop their own therapeutic protocol. Since virtually all specialty pharmacies are now accredited, it is incumbent on specialty pharmacies to develop such enhanced therapeutic protocols as new information becomes available.

The most noteworthy article element addressed medication dosing schedule adjustments for patients before / after receiving the Covid 19 vaccine.
“Medications include:
Methotrexate: Hold for one week after each vaccine dose for people with well-controlled disease.
JAK Inhibitors: Hold for one week after each dose.
Abatacept for subcutaneous delivery: Hold for one week before and one week after the first dose only; for IV delivery, time the first vaccine only to occur four weeks after the drug’s infusion, then postpone the subsequent infusion by one week, for a five-week gap.
Rituximab: Schedule vaccine about four weeks before next scheduled cycle and delay the drug two to four weeks after the vaccine series is completed, if possible.
Cyclophosphamide: Time drug administration about one week after each vaccine dose, if possible.
There were no recommendations to alter drug regimens for hydroxychloroquine, intravenous immunoglobulin (IVIG), prednisone less than 20 milligrams per day, sulfasalazine, leflunomide, mycophenolate, azathioprine, cyclophosphamide, TNF inhibitors, belimumab, oral calcineurin inhibitors, or IL-6R, IL-1, IL-17, IL-12/23, or IL-23.

It is possible that people taking immune-compromising medication may have a lower
response to the vaccine, the ACR Task Force notes.”

Does your specialty pharmacy support drug-specific dosing adjustments for your RA patients receiving the vaccine?
If not, why not?

Our suggestion is to use this template to prepare such enhanced protocols for each therapeutic category you support including desktop workflows for patient coordinators and pharmacists to determine if a dosing schedule adjustment is warranted. Notes to the patient file should include patient status and follow up to ensure that the specialty therapy resumes. A call to the treating physician may be required as well. Each manufacturer should be able to provide their dosing recommendation for their drug.

Developing a full suite of protocols will be challenging but is essential to a high-quality therapeutic management program.

8 Things People With Rheumatoid Arthritis Must Know About the COVID-19 Vaccines

Learn about the safety, effectiveness, and importance of getting the COVID-19 vaccines if you or a loved one is living with rheumatoid arthritis.

By Meryl Davids Landau
Medically Reviewed by Alexa Meara, MD

February 11, 2021 — With two COVID-19 vaccines already authorized by the U.S. Food and Drug Administration (FDA) and others potentially on the way, immunizations have begun in the United States and around the world. People living with rheumatoid arthritis (RA) and their loved ones may have questions about whether the vaccines are safe and effective for those with this condition.

Based on a substantial body of evidence, there is no need to hesitate, says Onyema Ogbuagu, MBBCh, an infectious disease specialist and a principal investigator of the Pfizer COVID-19 vaccine trial at the Yale School of Medicine in New Haven, Connecticut.

People with rheumatoid arthritis should roll up their sleeves as soon as a shot is offered to them, he says. With COVID-19 a widely circulating, deadly disease, it’s important to get protection as soon as you can. “Don’t delay. Do it yesterday,” he urges.

Below are expert answers to your pressing questions about the COVID-19 vaccines……..


FDA Approves New Tx for Ultra-Rare Condition – Evkeeza

Last week the FDA approved yet another uber expensive therapy, Evkeeza from Regeneron Pharmaceuticals, to treat homozygous familial hypercholesterolemia (HoFH), an ultra-rare inherited condition that affects approximately 1,300 patients in the U.S. and is characterized by extremely high low-density lipoprotein cholesterol (LDL-C)

Evkeeza is an infused therapy and is weight based. The recommended dosing regimen of Evkeeza is 15 mg per kilogram of body weight every 4 weeks. Evkeeza was also granted a pediatric indication and can be combined with other lipid lowering therapies. Evkeeza is the first FDA approved treatment that binds to and blocks the function of angiopoietin-like 3 (ANGPTL3), a protein that plays a key role in lipid metabolism.

Wholesale Acquisition Cost (WAC) per patient in the U.S. will vary based on weight and is expected to be approximately $450,000 per year on average.

Orsini Specialty Pharmacy, a leader in rare diseases and gene therapies, has announced that it has been selected by Regeneron Pharmaceuticals as the exclusive specialty pharmacy partner for Evkeeza. Product will be shipped direct to the treating physician office, another example of a limited distribution – direct-to-office (LD-DTO) program. Orsini will also provide HUB services including product information, insurance benefit verification, community resources and appointment reminders.

FDA Approves First-in-class Evkeeza for Patients with Ultra-rare Inherited Form of High Cholesterol

Feb. 11, 2021 /PRNewswire/ — Homozygous familial hypercholesterolemia (HoFH) is an ultra-rare inherited condition that affects approximately 1,300 patients in the U.S. and is characterized by extremely high low-density lipoprotein cholesterol (LDL-C)

In pivotal Phase 3 HoFH trial, adding Evkeeza to standard lipid-lowering therapies reduced LDL-C by nearly half at 24 weeks, compared to placebo

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) approved EvkeezaTM (evinacumab-dgnb) as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies to treat adult and pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH). Evkeeza is the first FDA-approved treatment that binds to and blocks the function of angiopoietin-like 3 (ANGPTL3), a protein that plays a key role in lipid metabolism.

“The FDA’s approval of Evkeeza is a watershed moment…………


FDA Approves New ORAL Tx for NSCLC – Tepmetko

Earlier this month the FDA approved a new ORAL therapy, Tepmetko (tepotinib) from EMD Serono, for the treatment of naïve and previously treated patients with advanced or metastatic NSCLC with MET exon 14 skipping alterations.

Tepmetko is the only FDA approved MET inhibitor that offers once-daily oral dosing and is administered as two 225 mg tablets (450 mg).

Tepmetko is a precision medicine that advances patient access to a targeted treatment highlighted by routine comprehensive biomarker testing. It works as a tyrosine kinase inhibitor that targets the tyrosine kinase MET. MET is an enzyme, a type of protein, that is involved in various cellular processes. Its activity is abnormal or increased in cancer, which may lead to the uncontrollable growth of cells and tumor development.

Patients with this aggressive lung cancer are often elderly and face a poor clinical prognosis.

Tepmetko is the second drug with the same indication. In May of 2020, the FDA approved Tabrecta (capmatinib) from Novartis. Merck hasn’t confirmed the cost of therapy for Tepmetko, however, the list price for Tabrecta is $17,950 for a 28-day supply. Analysts believe that the two therapies will compete on price in this small patient population.

Merck did not indicate if Tepmetko will launch through limited distribution. By way of reference, the competing Novartis product (Tabrecta) launched through LD last year. We expect that Tepmetko will follow suit.

FDA grants accelerated approval to tepotinib for metastatic non-small cell lung cancer

On February 3, 2021, the Food and Drug Administration granted accelerated approval to tepotinib (Tepmetko, EMD Serono Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.

Efficacy was demonstrated in the VISION trial (NCT02864992), a multicenter, non-randomized, open-label, multicohort study enrolling 152 patients with advanced or metastatic NSCLC with MET exon 14 skipping alterations. Patients received tepotinib 450 mg orally once daily until disease progression or unacceptable toxicity.

The main efficacy outcome measures were overall response rate (ORR) determined by a blinded independent review committee using RECIST 1.1 and response duration. Among the 69 treatment naïve patients, the ORR was 43% (95% CI: 32%, 56%) with a median response duration of 10.8 months (95% CI: 6.9, not estimable). Among the 83 previously treated patients, the ORR was 43% (95% CI: 33%, 55%) with a median response duration of 11.1 months (95% CI: 9.5, 18.5).

The most common adverse reactions (≥ 20% of patients) were edema, fatigue, nausea, diarrhea, musculoskeletal pain, and dyspnea. Tepotinib can also cause interstitial lung disease, hepatotoxicity, and embryo-fetal toxicity.

The recommended tepotinib dose is 450 mg orally once daily with food.

This indication is approved under accelerated approval based on overall response rate and response duration. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

This review used the Real-Time Oncology Review, which streamlined data submission prior to the filing of the entire clinical application. The review also used the Oncology Center of Excellence Assessment Aid and the Product Quality Assessment Aid (PQAA), voluntary submissions from the applicant to facilitate the FDA’s assessment.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this application, a modified Project Orbis was undertaken because of the timing of submission to other regulatory agencies. FDA collaborated with Health Canada, Therapeutic Goods Administration (Australia), and Swissmedic on this review.


FDA Approves New ORAL Tx for Lymphoma – Ukoniq

This week the FDA approved a new ORAL therapy, Ukoniq (umbralisib) from TG Therapeutics with indications for marginal zone lymphoma (MZL) and follicular lymphoma (FL). (See FDA press release below for indication details.)

Accelerated Approval was granted well in advance of its scheduled approval date. Ukoniq, a dual inhibitor of PI3K-delta and CK1-epsilon, had submitted Phase 2 trial data as recently as this past December.

Follicular lymphoma (FL) is typically an indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes. It is the second most common form of NHL. FL is generally not curable and is considered a chronic disease, as patients can live for many years with this form of lymphoma. With an annual incidence in the United States of approximately 13,200 newly diagnosed patients, FL is the most common indolent lymphoma accounting for approximately 17 percent of all NHL cases.

Pricing for Ukoniq was not available.

The trend to launch new therapies, especially in Oncology, through Limited Distribution continues in 2021. TG Therapeutics has announced that Onco360 will be its exclusive specialty pharmacy for this therapy.

FDA grants accelerated approval to umbralisib for marginal zone lymphoma and follicular

On February 5, 2021, the Food and Drug Administration granted accelerated approval to umbralisib (Ukoniq, TG Therapeutics), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for the following indications:

Adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen;
Adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.

Approval was based on two single-arm cohorts of an open-label, multi-center, multi-cohort trial, UTX-TGR-205 (NCT02793583), in 69 patients with MZL who received at least one prior therapy, including an anti-CD20 containing regimen, and in 117 patients with FL after at least 2 prior systemic therapies. Patients received umbralisib 800 mg orally once daily until disease progression or unacceptable toxicity.

Efficacy was based on overall response rate (ORR) and duration of response (DOR) using modified 2007 International Working Group criteria assessed by an independent review committee.

For patients with MZL, the ORR was 49% (95% CI: 37.0, 61.6) with 16% achieving complete responses. Median DOR was not reached (95% CI: 9.3, NE) in these patients. For patients with FL, the ORR was 43% (95% CI: 33.6, 52.2) with 3% achieving complete responses. Median DOR was 11.1 months (8.3, 16.4).

The most common (>15%) adverse reactions, including laboratory abnormalities, were increased creatinine, diarrhea-colitis, fatigue, nausea, neutropenia, transaminase elevation, musculoskeletal pain, anemia, thrombocytopenia, upper respiratory tract infection, vomiting, abdominal pain, decreased appetite, and rash. Serious adverse reactions occurred in 18% of patients, most often from diarrhea-colitis and infection. Diarrhea-colitis and transaminase elevation were the most common reasons for dose modifications.

The prescribing information provides warnings and precautions for adverse reactions including infections, neutropenia, diarrhea and non-infectious colitis, hepatotoxicity, and severe cutaneous reactions.

The recommended umbralisib dose is 800 mg taken orally once daily with food until disease progression or unacceptable toxicity.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

This application was granted priority review for the MZL indication and orphan drug designation was granted for the treatment of MZL and FL. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

The MZL and FL indications were granted accelerated approval based on overall response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.


FDA Approves New CAR-T Tx for Lymphoma – Breyanzi

Specialty pharmacies won’t be dispensing Breyanzi, approved by the FDA last week for the treatment of late-stage lymphoma with certain types of large B-cell lymphoma whose cancer has progressed after at least two prior treatments. This newly approved infused CAR-T therapy will be available only at select, vetted hospitals nationally.

The treatment is personalized, made up of a patient’s own immune cells extracted and shipped to special manufacturing facilities. There, the cells are genetically modified to target a particular protein that acts as a flag for the cancer. The modified cells are manipulated to create a 1 time treatment dose that is shipped back to the facility for infusion. One may even ask if it qualifies as a ‘medicine’.

Breyanzi will hit the market three years after the approvals in lymphoma of CAR-T cell therapies Yescarta (Gilead) and Kymriah (Novartis). Neither treatment is a big seller, with use mostly confined to blood cancer patients who have run out of traditional therapy options.

The FDA approved Breyanzi with a black box warning for the risk of neurotoxicity and a type of immune overreaction known as cytokine release syndrome associated with cell therapy. The FDA requires patients to be monitored in person or remotely for the first week after infusion and they must remain close to the facility for at least three more weeks. Bristol Myers will also provide wearable temperature monitors.

So why should specialty pharmacies want to know about a therapy that they can’t dispense?

More than 500 gene-based therapies are in development. So, specialty pharmacies should be concerned. We may start seeing even the most recent generation of ‘wonder drugs’ dispensed by SPs replaced by 1 dose gene therapies.

Also, SPs that work the Oncology segment should know about ALL specialty therapies in the toolbox. With more approvals of such space age therapies such expertise is important to build credibility with patients and Oncologists.

Bristol Myers will charge a list price of $410,300 for Breyanzi. Both Gilead and Novartis offer their competing therapies at ~$373,000. Bristol Myers did not mention offering any results-based financial guarantees.

Is this term in your pharmaceutical vocabulary?…… CAR-T.
CAR-T stands for chimeric antigen receptor T cell (CAR-T) therapy in which T-cells are extracted from a patient’s white blood cells and genetically modified in special facilities to target a specific protein that binds to cancer cells. The modified cells are then infused in the patient.

FDA Approves New Treatment For Adults With Relapsed Or Refractory Large-B-Cell Lymphoma

February 05, 2021 — The U.S. Food and Drug Administration has approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment. Breyanzi, a chimeric antigen receptor (CAR) T cell therapy, is the third gene therapy approved by the FDA for certain types of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL). Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma.

“Today’s approval represents another milestone in the rapidly progressing field of gene therapy by providing an additional treatment option for adults with certain types of cancer affecting the blood, bone marrow, and lymph nodes,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Gene and cell therapies have evolved from promising concepts to practical cancer treatment regimens.”

DLBCL is the most common type of non-Hodgkin lymphoma in adults. Non-Hodgkin lymphomas are cancers that begin in certain cells of the immune system and can be either fast-growing (aggressive) or slow-growing. Approximately 77,000 new cases of non-Hodgkin lymphoma are diagnosed in the U.S. each year and DLBCL represents approximately one in three newly diagnosed cases.

Each dose of Breyanzi is a customized treatment created using a patient’s own T-cells, a type of white blood cell, to help fight the lymphoma. The patient’s T-cells are collected and genetically modified to include a new gene that facilitates targeting and killing of the lymphoma cells. Once the cells are modified, they are infused back into the patient.

The safety and efficacy of Breyanzi were established in a multicenter clinical trial of more than 250 adults with refractory or relapsed large B-cell lymphoma. The complete remission rate after treatment with Breyanzi was 54%.

Treatment with Breyanzi has the potential to cause severe side effects. The labeling carries a boxed warning for cytokine release syndrome (CRS), which is a systemic response to the activation and proliferation of CAR T cells, causing high fever and flu-like symptoms and neurologic toxicities. Both CRS and neurological events can be life-threatening. Other side effects include hypersensitivity reactions, serious infections, low blood cell counts and a weakened immune system. Side effects generally appear within the first one to two weeks following treatment, but some side effects may occur later.

Because of the risk of CRS and neurologic toxicities, Breyanzi is being approved with a risk evaluation and mitigation strategy (REMS) which includes elements to assure safe use (ETASU). The FDA is requiring, among other things, that healthcare facilities that dispense Breyanzi be specially certified. As part of that certification, staff involved in the prescribing, dispensing or administering of Breyanzi are required to be trained to recognize and manage the risks of CRS and neurologic toxicities. The REMS program specifies that patients be informed of the signs and symptoms of CRS and neurological toxicities following infusion – and of the importance of promptly returning to the treatment site if they develop fever or other adverse reactions after receiving treatment with Breyanzi.

To further evaluate the long-term safety, the FDA is also requiring the manufacturer to conduct a post-marketing observational study involving patients treated with Breyanzi.

The FDA granted Breyanzi Orphan Drug, Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy designations. The RMAT designation program was created under the 21st Century Cures Act to help facilitate the expeditious development of regenerative medicine therapies intended for serious conditions. Breyanzi is the first regenerative medicine therapy with RMAT designation to be licensed by the FDA. Orphan Drug designation provides incentives to assist and encourage the development of drugs for rare diseases. The Breyanzi application was reviewed using a coordinated, cross-agency approach, including both the Center for Biologics Evaluation and Research and FDA’s Oncology Center of Excellence.

The FDA granted approval of Breyanzi to Juno Therapeutics Inc., a Bristol-Myers Squibb Company.


New LD-DTO Solutions Likely

During 2020 we saw a measurable uptick in the number of FDA approved therapies that were LD-DTO….. which you should know stands for Limited Distribution, Direct-to-Office (LD-DTO) for office administration. 

Manufacturers have gotten very comfortable with specialty pharmacies dispensing their products and managing patients through traditional Limited Distribution (LD) direct to patient. They are rapidly warming up to the idea of specialty pharmacies also handling their buy-and-bill meds, especially for orphan drugs and those that may be out of the ordinary and in need of some ‘specialty’ tender lovin’ care. 

Here’s an example of a new application of LD-DTO that we tripped across recently. 

Orsini Specialty Pharmacy was selected some months ago by Glaukos Manufacturing to manage a drug originally launched in 2016. The therapy, Photrexa / Photrexa Viscous, is shipped DTO and is used incident to a procedure called corneal collagen cross-linking (CXL) by a corneal specialist. 

So why go to Orsini to set up a specialty pharmacy LD-DTO solution years after original launch? The specialists were still running into reimbursement issues, challenges with inventorying high cost therapy, and complicated billing practices as the drug incident to an eye laser procedure. 

The drug has an AWP of $3750 per eye….. so it is in the specialty pharmacy sweet spot. Orsini has worked with payers and PBMs to open up the AOB billing option and those efforts are paying off. Specialists and patients are equally enjoying the journey on increasingly smoother roads. 

As other manufacturers see the benefits of such a relationship we will likely see more LD-DTO deals in the future.    


Orsini Specialty Pharmacy Selected By Glaukos® Corporation As A Specialty Pharmacy Distribution Partner For Photrexa® And Photrexa® Viscous 

ELK GROVE VILLAGE, Ill., Jan. 19, 2021 /PRNewswire/ — Orsini Specialty Pharmacy, a leader in rare diseases and gene therapies, announced today that it has been selected by Glaukos® Corporation as a specialty pharmacy distribution partner for Photrexa® (riboflavin 5′-phosphate ophthalmic solution) and Photrexa® Viscous (riboflavin 5′-phosphate in 20% dextran ophthalmic solution) for the treatment of patients with progressive keratoconus and corneal ectasia following refractive surgery. Using Photrexa Viscous and Photrexa with a proprietary UV light delivery system, Glaukos’ iLink™ corneal cross-linking procedure is the first and only FDA approved therapeutic treatment that strengthens the cornea to slow or halt the progression of keratoconus. 

Keratoconus is a rare, degenerative eye condition that occurs when the normally dome-shaped cornea weakens and begins to bulge into a cone-like shape resulting in vision loss. Keratoconus often appears in individuals who are in their late teens to early 20s and occurs in approximately 1 out of every 2,000 people in the United States.   

“We are honored to be Glaukos’ specialty pharmacy partner for Photrexa, which offers hope for individuals with progressive keratoconus,” said Mike Fieri, Orsini Chief Executive Officer. “Our dedicated Photrexa Care Team is committed to providing high touch, individualized services for people with this condition.” 

Tim Homer, Vice-President of Global Market Access added, “We at Glaukos are excited to partner with Orsini. This partnership offers our providers the option of obtaining Photrexa through a specialty pharmacy so they can focus on providing access to the iLink procedure to their patients.” 

About Orsini Specialty PharmacyProviding patients with comprehensive and compassionate care since 1987, Orsini is a leading, independent specialty pharmacy focused on rare and ultra-rare diseases and gene therapies. Orsini’s high touch care model is centered around experienced, therapy-specific care teams who provide personalized care to patients based on their specific condition and treatment. The company’s comprehensive solutions include medication adherence programs, data analytics, customized manufacturer programs and nationwide nursing coverage for convenient in-home infusion services. Headquartered in Elk Grove Village, IL, Orsini Specialty Pharmacy holds accreditations with the Accreditation Commission for Health Care (ACHC), The Joint Commission, URAC, NABP, and most recently was awarded ACHC’s Distinction in Rare Diseases and Orphan Drugs. 

About Glaukos CorporationGlaukos ( is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in July 2012, its next-generation iStent inject® device in the United States in September 2018 and most recently, its iStent injectW device in the United States in October 2020. In corneal health, Glaukos’ proprietary suite of single-use, bio-activated pharmaceuticals are designed to strengthen, stabilize and reshape the cornea through a process called corneal collagen cross-linking to treat corneal ectatic disorders and correct refractive conditions. Glaukos is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies in glaucoma, corneal health and retinal disease. 

For more information about Orsini’s specialty pharmacy services, contact us at 847-734-7373 ext. 545, e-mail us at, or visit

iLink™ is a trademark of Glaukos Corporation. Glaukos and Photrexa® are registered trademarks of Glaukos Corporation.


FDA Approves New Tx for Lupus – Lupkynis

The FDA has approved a new, first ever therapy for Lupus nephritis, Lupkynis (voclosporin) from Aurinia Pharmaceuticals, in combination with background immunosuppressive therapy. It is indicated for the treatment of adult patients with active lupus nephritis (LN) . Lupus nephritis (LN) is a serious progression of SLE, a chronic, complex, and autoimmune disease.

Lupkynis has been approved with a black box warning including malignancies and serious infections.

About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals, +-85,000, have already developed LN at the time of SLE diagnosis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure.

In the past, repurposed anti-inflammation drugs, steroids, immunosuppressants and antimalarials like hydroxychloroquine were the only options to manage lupus symptoms. The last approval for LN was ten years ago in 2011, Benlysta.

Aurinia announced in an investor call that it has targeted ~12,000 physicians in the rollout and has already approached ~50 payers that cover two-thirds of LN lives in the US.

Forecasting patient cost is not easy.
Aurinia announced a list price of $3,950 for 60 capsules. But that translates into only 10 days of therapy at the start up (also ongoing) dosing schedule. However, the label details complex dose reductions based on close physician monitoring and lab results especially in the first months. So, a patient that well tolerates the drug will require a maximum of 180 capsules a month….. that’s ~$12,000. A patient with complications may see dose reduction by up to two thirds, requiring only 2 tablets a day / 60 tablets a month….. that’s ~$4,000. Analysts suggest that once up and running the weighted average annual cost of therapy will likely top out at about $65,000.

Aurinia did not release distribution details. We expect that Lupkynis will launch into specialty pharmacy limited distribution given the cost of therapy, a black box warning, a complex dosing regimen, and testing for adverse reactions long term.

FDA Approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for Adult Patients with Active Lupus Nephritis

  • LUPKYNIS is the first FDA-approved oral therapy for lupus nephritis (LN), a condition that causes irreversible kidney damage and increases the risk of kidney failure, cardiac events, and death –
  • LUPKYNIS demonstrated significantly improved renal response rates compared to typical standard-of-care (SoC) in clinical trials
  • LUPKYNIS is now commercially available in the U.S. – JANUARY 22, 2021 VICTORIA, British Columbia & ROCKVILLE, Md.–(BUSINESS WIRE)– Aurinia Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved LUPKYNIS (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). LUPKYNIS is the first FDA-approved oral therapy for LN. LN causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. It is one of the most serious and common complications of the autoimmune disease systemic lupus erythematosus (SLE). LUPKYNIS is now available to patients in the United States (U.S.).

In pivotal trials,………………………

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