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FDA Approval of Postpartum Oral Tx – Zurzuvae

……catching up on FDA approvals

The FDA approved an oral therapy, Zurzuvae (zuranolone) from Biogen Inc./ Sage Therapeutics, Inc.)  Zurzuvae is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression (PPD) in adults. 

About 1 in 8 women in the U.S. (that’s about .5 million out of 3.7 million live births in the US) experience symptoms of postpartum depression following birth.  Postpartum depression lasts for weeks or months. It generally starts about 1-3 weeks after giving birth.

This approval came about a number of months ago….. but the companies indicated that launch would be delayed till Q1-2024. 

The package insert specifies that Zurzuvae should be administered with fat-containing food. It has a recommended dosage is 50 mg orally once daily in the evening for 14 days.  Other strengths are available to down dose in the event of CNS effects, Renal, or Hepatic impairment. Approval included a black box warning….. especially related to CNS concerns. There is no mention relative to continuation of this therapy past the initial 14 days.

Most noteworthy is the price set by the companies….. $15,900 for just the two-week course of treatment.

Biogen /Sage has yet to issue any details as to distribution. Given its price, relatively limited demand, and need to monitor for warnings and reactions, it is likely going to be made available through limited distribution.


Biogen, Sage set price of postpartum depression pill at $15,900

Biogen and Sage Therapeutics will charge a sticker price of nearly $16,000 for a two-week course of their new postpartum depression drug Zurzuvae, the companies revealed Tuesday.

CLICK HERE to read the full article


FDA Approves IV and Sub-q Forms for UC – Omvoh

The FDA recently approved a new therapy, Omvoh (mirikizumab-mrkz) from Eli Lilly and Company, for the treatment of moderately to severely active ulcerative colitis (UC) in adults. 

Most noteworthy is that Omvoh is available in both Infused and Subcutaneous forms. 

· The recommended induction dosage is 300 mg by intravenous infusion at weeks 0, 4, and 8.

·    The recommended maintenance dosage is 200 mg administered by subcutaneous injection (given as two consecutive injections of 100 mg each) at Week 12, and every 4 weeks thereafter. 

Ulcerative colitis is a type of inflammatory bowel disease (IBD). It causes inflammation and ulcers, or sores, in the large intestine. Scientists still do not know the main cause of ulcerative colitis, however, environmental factors, imbalance in the gut and immune system are suspected leading contributors. Genetics also play a role in ulcerative colitis, as well as age (most are diagnosed between the ages of 15 and 30.) and ethnicity as Caucasians and those of Ashkenazi Jewish descent are at a higher risk for developing the disease.

Symptoms range from mild to severe with periods of worsening symptoms — called flares — and diminished symptoms — called remission — occurring over time.

Common symptoms of ulcerative colitis include:

·        nausea

·        diarrhea

·        bloody stools with mucus

·        abdominal pain or cramping

·        inability to pass stools despite frequent urges

·        rectal bleeding

·        fatigue

·        unintentional weight loss

·        loss of appetite

·        dehydration

Omvoh has a list price of $9,593 per month for the IV formulation and $10,360 per subcutaneous administration. It is presumed that access to the IV form will be through national distributors. Lilly has not announced whether the subcutaneous form will be restricted to limited distribution.

CLICK HERE to read prescribing information


FDA Approves Lilly’s Omvoh (mirikizumab-mrkz), A First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis

·        Omvoh delivered significant improvement in bowel urgency, reported by people with UC 

·        Lilly’s first approved treatment for a type of inflammatory bowel disease

INDIANAPOLIS, /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Omvoh™ (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL), the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

Marking a significant milestone, Omvoh is the only UC treatment that selectively targets the p19 subunit of IL-23, which plays a role in inflammation related to UC.

CLICK HERE to read the full Lilly press release


ESI to Try Cost-Plus Model

Mark Cuban can now be called a pharmacy trend setter. 

We’ve read about his cost-plus drugs model….. and it seems that Express Scripts (ESI) feels that offering a similar pricing model to their clients is a great idea. 

Yeah, one PBM may not qualify as a trend….. but it is a start.

ESI has begun to offer a product called ClearNetwork to clients using Wholesale Acquisition Cost, Predictive Acquisition Cost, or National Average Drug Acquisition Cost to decide on the ‘’estimated’ price for each drug in their formulary. A pharmacy fee and a second fee of 15% then added (not clear if that is a combined 15% or two separate fees). ESI has been quoted as saying that the fees will be transparent to clients and pharmacies (no mention of patients, however).

According to the article below, “The option will apply to a plan sponsor’s list of covered generic, branded and specialty medications.” This model is being offered to the 65,000 retail pharmacies in its network. It is not clear is participation is part of the recontracting going on where pharmacy reimbursements are being cut significantly.

ESI will add fees onto each prescription to cover its cost for providing its package of PBM services.


Express Scripts’ New Option Models Mark Cuban’s Cost Plus Drugs

This is the latest offering by Express Scripts that aims to bring transparency to prescription drug costs.

CLICK HERE to read the full article


FDA Approves Interchangeable Biosim to Stelara – Wezlana

…………catching up on FDA approvals

The FDA has approved a new therapy, Wezlana (ustekinumab-auub) from Amgen, Inc., as a biosimilar to Janssen Biotech’s Stelara. Wezlana is available in a subcutaneous form as well as an infusible. . Wezlana joins the ranks of only a handful of biosimilars to also earn the title if interchangeability with the reference product. 

Wezlana is indicated for—–

Adult patients with:

  • moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, 
  • active psoriatic arthritis;
  • moderately to severely active Crohn’s disease; and
  • moderately to severely active ulcerative colitis.

Pediatric patients 6 years of age and older with:

  • moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and 
  • active psoriatic arthritis.

Prescribing information specifies subcutaneous dosing and administration for Psoriasis and Psoriatic Arthritis while specifying intravenous dosing instructions for Crohn’s Disease and Ulcerative Colitis.

CLICK HERE for prescribing information

While Wezlana did not receive a Black Box warning there are a number of warnings and precautions.

Amgen intends to launch Wezlana in early 2025 when Stelara’s patent exclusivity expires. As such, pricing and distribution plans were not announced.


FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases

CLICK HERE to read the FDA press release


Two Hospital Systems Get Hitched to do Specialty

Here’s an interesting new twist on hospitals and health systems opening their own specialty pharmacies….. PA-based Geisinger Clinic and NY-based Bassett Healthcare are getting hitched to do exactly that.

Hospital systems tend to be monolithic. However, as the master might say “There may be great wisdom, grasshopper, to share great burdens.” Let’s put that into business terms….. economy, efficiency, utility, scope, and leverage come to mind.

It is expensive to start a large SP operation from scratch…. so sharing costs…. Economy

Sharing operations… everything from IT to toilet paper…… Efficiency

Squeeze the best ROI from investments in hardware, dispensing gear, etc…. Utility

Size still matters when it comes to geography….. patients….. Scope

Last, and certainly not least, purchasing power with manufacturers and suppliers….. Leverage

Our list is not exhaustive but gives some insight on why the marriage may be made in pharmacy heaven. It is interesting that this is a home grown initiative with no mention of a third party specialty pharmacy ‘growth accelerator’ behind the curtain.


Bassett Healthcare Network Partnering with Geisinger on Plans to Open Specialty Pharmacy in 2024

CLICK HERE to read the full article


FDA Approved a New Tx for DMD – Agamree

There was a big development for DMA patients last June with the FDA approval of Elevidys (delandistrogene moxeparvovec-rokl) from Sarepta Therapeutics. Elevidys was the first and only gene therapy approved for Duchenne Muscular Dystrophy (DMD). But there was were two hitches in the giddyap…it was approved only for patients with a confirmed mutation in the DMD gene, and, its $3.2 million cost makes  access a real obstacle. 

We missed covering the more recent approval of another therapy for DMD that is not a gene therapy….. but one that has broad application in the category. The FDA approved Agamree (vamorolone) from Santhera Pharmaceuticals, a novel corticosteroid with favorable side effects.  It is provided in an oral suspension form. 

It is estimated that between 11,000 and 13,000 patients in the U.S. are affected by DMD, with approximately 70% of patients currently receiving concomitant corticosteroid treatment. DMD, is the most common form of muscular dystrophy, is a rare and life-threatening neuromuscular disorder characterized by progressive muscle dysfunction, ultimately leading to loss of ambulation, respiratory failure, and death. 

Click Here for prescribing information

Catalyst holds the exclusive north American license to commercialize Agamree.

Pricing for Agamree is not nearly as costly as the big ticket gene therapy at under $10,000 per year for most patients based on weight. There has been no update on limited distribution.


Catalyst Pharmaceuticals Reports FDA Approval of AGAMREE® (vamorolone) for Duchenne Muscular Dystrophy Granted to Santhera Pharmaceuticals

CLICK HERE to read the full Catalyst press release


You Can Now Make a Drug Using a 3D Printer

I always enjoy news about innovative developments in pharmacy. 

The article below tickled our interest.

The article details how Texas A&M has successfully developed a breakthrough compounding technique using 3D Printing to create patient-specific doses especially targeting children as an underserved patient segment.

First, there are many solid drugs where even the lowest manufacturer strength is inappropriate for children. Compounding has always been the go-to alternative in that case. Secondly, kids usually don’t like to take medicine….. and even a compounded liquid option is often a battle to administer. 

Imagine if you will…. a compounded, dose-appropriate 3D tablet with a yummy tasting coating. 

This sounds like a winner-winner chicken dinner option for many children.

Most specialty pharmacies don’t do compounding. However, there are about 7,500 compounding pharmacies in the US and 3D printing of certain drugs could be a great addition to their toolboxes. Whether 3D printing has a ‘fit’ in specialty pharmacy is not clear…. but, some visionary specialty pharmacist out there might be smarter than this commentator.


3D Printing Could Create Tailored Medications for Children

Pharmacists and engineers at Texas A&M University, in College Station, have developed a 3D printing process capable of producing the exact dose of medication needed by a child, meant to be used in hospitals and pharmacies on an as-needed basis.

CLICK HERE to access the full article

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