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Announcements for newly approved specialty drugs often state that the product will be available through specialty pharmacy in limited distribution. However, the press releases rarely specify the specialty pharmacy(ies) selected as the designated partner(s).

Here are two LD deals that have been recently publicly confirmed subsequent to the approvals.

Amber Specialty Pharmacy and Hy-Vee Pharmacy Solutions Selected to Dispense TEZSPIRE™ (tezepelumab) for the Treatment of Severe Asthma
OMAHA, Neb.–(BUSINESS WIRE)–Amber Specialty Pharmacy and Hy-Vee Pharmacy Solutions announce today that they are now dispensing TEZSPIRE™ (tezepelumab), the first biologic to significantly reduce exacerbations in broad populations of patients with severe, uncontrolled asthma. TEZSPIRE™ is a collaborative product, developed and manufactured by Amgen and AstraZeneca.

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PANTHERx Rare® Selected by Xeris Pharmaceuticals to Distribute Recorlev® (levoketoconazole) for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome
PANTHERx Rare announces that it has been selected by Xeris Pharmaceuticals, Inc., a wholly owned subsidiary of Xeris Biopharma Holdings, Inc., as the exclusive U.S. pharmacy distribution partner for a new FDA-approved medication, Recorlev® (levoketoconazole). Recorlev is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. Cushing’s syndrome, a disease associated with increased production of cortisol, occurs most commonly in adults between ages 30-50 and affects women two times more often than men.

The FDA just approved not ONE, but TWO therapies in the already crowded immunology category.

The two include a new NDA for Cibinqo (abrocitinib) from Pfizer and an expanded indication for well established Rinvoq (upadacitinib).

Let’s look first at Cibinqo —

The FDA approved Cibinqo (abrocitinib) from Pfizer, for the treatment of adults living with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Cibinqo is a once-daily oral. Like its leading competing therapies, it is a Janus kinase 1 (JAK1) inhibitor. Cibinqo is a human monoclonal antibody that inhibits interleukin-13 (IL-13), a cytokine which plays a key role in AD inflammation.
Cibinqo comes with a boxed warning due to observed risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB), a higher rate of lymphomas and lung cancers, cardiovascular death, myocardial infarction, thrombosis, and stroke.

CIBINQO is not approved for use in RA patients.

Pfizer did not announce distribution details. Given the black box warning and the expected cost for Cibinqo, one might expect that it will launch through specialty pharmacy limited distribution. However, Rinvoq is not in limited distribution.

So what about Rinvoq?

Rinvoq was granted an expanded indication for the treatment of adults living with refractory, moderate-to-severe atopic dermatitis (AD). Since its original approval in 2019 for RA. Rinvoq has since established a strong niche in the marketplace. Efficacy between Cibinqo and Rinvoq are comparable. However, Rinvoq’s approval included children 12 and over (vs. Cibinqo’s approval for adults only) although it also carries a black box warning. 

Oh, and what about Adbry? 

Just last month the FDA approved yet another JAK1 inhibitor therapy, Adbry, also with the AD indication. However, Adbry is an injectable, which may hinder its uptake vs. the newly approved Cibinqo and the newly upgraded Rinvoq….. (both Cibinqo and Rinvoq are orals).

Atopic Dermatitis – 

There are an estimated 16.5 million adults in the U.S. living with atopic dermatitis, with approximately 6.6 million categorized as living with moderate-to-severe disease

What about COST? 

Pricing for Cibinqo was not announced at the time of approval. Various sources suggest the following anticipated price ranges for the leading competing products. 

• Cibinqo       — $35,000-$42,000 per year (estimate) for AD
• Adbry         — $35,000-$40,000 per year (estimate) for AD
• Olumiant    — $24,400-$33,300 per year (US list: $29,000, limited distribution) for RA
• Rinvoq        — $30,400-$41,500 per year (with GoodRx coupon $5500/mo.) for AD and RA
• Dupixent    — $29,000-$39,500 per year ($5300 month, limited distribution) for AD, subQ

CLICK HERE to access Cibinqo prescribing information https://cdn.pfizer.com/pfizercom/USPI_Med_Guide_CIBINQO_Abrocitinib_tablet.pdf

CLICK HERE to access the Pfizer press release for Cibinqohttps://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-cibinqor-abrocitinib-adults

At the end of December, the FDA approved yet another biosimilar, Yusimry (adalimumab-aqvh) from Coherus Bioscience. Yusimry is a tumor necrosis factor blocker approved as a subcutaneous formulation. It is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis.

Yusimry is the seventh biosimilar to be approved for AbbVie’s blockbuster Humira (adalimumab).

This approval marks the thirty third (33) biosimilar in the US and the 7th biosimilar to Humira. None of the Humira biosims are currently available for sale in the US. Per the terms of its agreement with AbbVie, Coherus (as with the others) will launch in the U.S. in July of 2023.

Last year was a lean year for new biosimilar approvals….. only four products. That compares poorly compared with 2019 when 10 biosimilars were approved.

Pricing for Yusimry is unlikely to be released until the product is close to its 2023 launch date.

Last week the FDA approved a new ORAL therapy, Recorlev (levoketoconazole) from Xeris Biopharma Holdings, for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. 

Cushing’s is a rare disease and Recorlev was granted an Orphan designation. There are fewer than 20,000 individuals with a Cushing’s diagnosis in the US and fewer with the endogenous hypercortisolemia diagnosis. 

Xeris did not announce pricing for Recorlev. The therapy is a next generation version of ketoconazole (tablets), a relatively inexpensive drug but not indicated for endogenous hypercortisolemia. That being said, there are plenty of examples where the new therapy is priced well above its sister legacy formulation. Several therapies have been approved for Cushing’s in recent years and all are considered specialty therapies. 

Xeris did not announce distribution details for Recorlev, however, they have launched a patient support HUB which has all the hallmarks of using the specialty pharmacy channel. Recorlev will be available later in Q1-22.

Click here to access prescribing information

We are catching up on the wave of FDA approvals that happen in the waning hours of the year.

The FDA approved Apretude (cabotegravir), from Viiv, for use in at-risk adults and adolescents for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.

Apretude is an extended-release injectable suspension as a gluteal intramuscular injection only . It is first administered as two initiation injections one month apart, and then every two months thereafter (total of 6 doses in year 1). Patients can start treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug.

Uptake has increased measurably since the introduction of Truvada, an oral medication also indicated for PrEP. However, compliance with the daily oral regimen has not been exemplary. It is believed that a periodic injection of Apretude will increase compliance rates.

Apretude includes a boxed warning to not use the drug unless a negative HIV test is confirmed. It must only be prescribed to individuals confirmed to be HIV-negative immediately prior to starting the drug and before each injection to reduce the risk of developing drug resistance. It appears that this testing requirement will mean that patients will be seeing a healthcare professional for the testing and injection.

Apretude has a list price of $3,700 per dose (or $22,200 per year, for six doses). By comparison, Truvada (brand) is priced at $21,000 per year. However, Truvada is also now available as a generic priced at a very low cost of $500 annually with a coupon.

Apretude is expected to ship to wholesalers and specialty distributors in early 2022.

In the final hours of 2021, the FDA approved a number of new drugs. One of these therapies is Adbry (tralokinumab-ldrm) from Leo Pharma. Adbry, an interleukin-13 antagonist, is indicated for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Tralokinumab is a human monoclonal antibody that inhibits interleukin-13 (IL-13), a cytokine which plays a key role in AD inflammation.

There are an estimated 16.5 million adults in the U.S. living with atopic dermatitis, with approximately 6.6 million categorized as living with moderate-to-severe disease

Leo Pharma did not announce pricing at this time.
ICER published the following price references (including their estimate for Adbry):
Tralokinumab (Adbry) — $25,700-$35,000 per year (estimate)
Abrocitinib — $30,600-$41,800 per year.
Olumiant — $24,400-$33,300 per year (US list price: $29,000)
Rinvoq — $30,400-$41,500 per year (US list price: $64,300)
Dupixent — $29,000-$39,500 per year (US list price: $41,800)

Adbry is supplied in 150 mg pre-filled syringes for Sub-Q administration. The initial dose of 600 mg (four 150 mg injections) is followed by 300 mg (two 150 mg injections) administered every other week.

Adbry is the first biologic launched by LEO Pharma in the United States and is expected to be available in pharmacies by February 2022. Given the size of the size of the potential patient population and that the other therapies in this segment are not in limited distribution, it is likely Adbry will not be launched through LD.

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LEO Pharma announces FDA approval of Adbry (tralokinumab-ldrm)

The first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis

MADISON, N.J. — December 28, 2021 (BUSINESS WIRE)–LEO Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Adbry (tralokinumab-ldrm) for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Adbry can be used with or without topical corticosteroids. Adbry is the first and only FDA approved biologic that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms.1,3,4

“Adbry will be an important addition to our therapeutic armamentarium as a treatment designed to specifically target and neutralize the IL-13 cytokine, thereby, helping patients manage their atopic dermatitis.”

“Today’s FDA approval of Adbry is a major milestone for LEO Pharma and for the millions of people living with moderate-to-severe atopic dermatitis who struggle to find effective control for this chronic and debilitating disease,” said Anders Kronborg, Chief Financial Officer and Acting Chief Executive Officer of LEO Pharma A/S. “As our first biologic in the U.S., Adbry signifies important progress in our mission of advancing the standard of care in medical dermatology.”

The approval of Adbry is based on safety and efficacy results from the ECZTRA 1, 2 and ECZTRA 3 pivotal Phase 3 trials, which included nearly 2,000 adult patients with moderate-to-severe atopic dermatitis.1 Safety data was evaluated from a pool of five randomized, double-blind, placebo-controlled trials, including ECZTRA 1, 2 and ECZTRA 3, a dose-finding trial, and a vaccine response trial.1

In all three pivotal trials, Adbry 300 mg every other week alone or with topical corticosteroids (TCS) as needed met the primary endpoints at Week 16 as measured by an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and/or at least a 75% improvement in the Eczema Area and Severity Index score (EASI-75), and the secondary endpoint of reduction of weekly average Worst Daily Pruritus NRS of ≥ 4 points on the 11-point itch NRS.1

In clinical trials, the safety of Adbry was well established with an overall frequency of adverse events comparable with placebo.1 The most common adverse events (incidence ≥1% and greater than placebo) were upper respiratory tract infections (mainly reported as common cold), conjunctivitis, injection site reactions, and eosinophilia.1

“Atopic dermatitis can be severe and unpredictable, which makes it not only challenging for patients to achieve long-term disease control, but also for clinicians to treat, since there are limited treatment options for this burdensome chronic skin disease,” said Jonathan Silverberg, MD, PhD, MPH, Associate Professor of Dermatology at George Washington University School of Medicine and Health Sciences, and tralokinumab clinical trial investigator. “Adbry will be an important addition to our therapeutic armamentarium as a treatment designed to specifically target and neutralize the IL-13 cytokine, thereby, helping patients manage their atopic dermatitis.”

Last week the FDA approved Leqvio, from Novartis Pharmaceuticals. Leqvio is a first-in-class, RNAi sub-Q therapy indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low density lipoprotein cholesterol (LDL-C).

The startup dose is given via subcutaneous injection by a healthcare professional. The next dose is given after 3 months with subsequent doses every 6 months. Before starting Leqvio the patient should be on a diet to lower cholesterol and a statin.

Novartis priced Leqvio at $3,250 per dose in the U.S., meaning the first year of treatment will cost $9,750 and subsequent years $6,500. That range falls in line with the current list prices of two existing PCSK9 therapies—around $5,400 to $5,850 for Amgen’s Repatha and Regeneron’s Praluent.

As an in-office procedure, Leqvio injections will be covered under the Medicare Part B. But, coverage through Part B could be an advantage for Leqvio over Repatha and Praluent. Physicians will be reimbursed for Leqvio ASP plus 6%. The other two drugs are covered by Part D under the pharmacy benefit.

Given the relatively large patient population and relatively low cost for a specialty drug, it is unlikely that Leqvio will be channeled through a limited distribution specialty pharmacy program. Leqvio qualifies as a specialty pharmacy therapy mainly because it ‘fits’ the specialty class of therapy carved out by Repatha and Praluent.

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FDA approves add-on therapy to lower cholesterol among certain high-risk adults

FDA has approved Leqvio (inclisiran) injection as a treatment to be used along with diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Leqvio works to reduce circulating levels of LDL-C, commonly known as “bad cholesterol.”

Leqvio is approved at a 284 mg dose administered as an initial under-the skin injection, a second dose at three months, and continued treatment once every six months after that point.

Diseases or Conditions
HeFH is a life-threatening condition in which patients have a mutation in a small group of genes that controls the way the body clears cholesterol. As a result, patients have extremely high levels of LDL-C. People with HeFH generally have cholesterol levels two to three times higher than normal. These individuals are at increased risk of cardiovascular events, such as heart attack, stroke, and coronary artery disease. HeFH occurs in approximately 1 in 250 individuals.

ASCVD involves the buildup of cholesterol plaque in arteries. Approximately 18.3 million American adults (8%) have ASCVD. Clinical ASCVD is an umbrella term and includes conditions such as acute coronary syndromes (sudden, reduced blood flow to the heart), peripheral arterial disease, heart attack and stroke.

Effectiveness
The effectiveness of Leqvio was studied in three randomized, double-blind, placebo-controlled trials that enrolled 3,457 adults with HeFH or clinical ASCVD. Enrolled participants were taking maximally tolerated statin therapy but required additional LDL-C lowering based on their risk for cardiovascular events. In all three studies, the main effectiveness outcome measure was the percent change in LDL-C from the beginning of the trial to day 510 (month 17). In each trial, participants received under-the-skin injections of either 284 mg Leqvio or a placebo on four separate days: day 1, day 90 (month 3), day 270 (month 9), and day 450 (month 15).

Study 1 enrolled 1,561 adults with ASCVD. At day 510, the Leqvio group had an average LDL-C decrease of 51% whereas the placebo group had an average LDL-C increase of 1%. Study 2 enrolled 1,414 adults with ASCVD. At day 510, the Leqvio group had an average LDL-C decrease of 46% whereas the placebo group had an average LDL-C increase of 4%. Study 3 enrolled 482 adults with HeFH. At day 510, the Leqvio group had an average LDL-C decrease of 40% whereas the placebo group had an average LDL-C increase of 8%.

The public relations battle surrounding White Bagging is heating up. Who’s on each side?

Depends on who you ask….!

• On one side, hospitals are claiming that their very existence is being threatened due to White Bagging policies.
• On the other side are the PBMs and the payers.

But, is there yet a third side? We will get to that. 

First, what is White Bagging?

As defined by the hospitals in the article link below….. White Bagging consists of “policies that require hospitals administering certain high-cost medications in an outpatient setting [actually inpatient as well] to receive those medications from third parties contracted with the health plan, instead of providing those medications directly from the hospital pharmacy inventories.” Increasingly, those third parties are specialty pharmacies acting as specialty distributors, under a distributor’s license (no prescription required) or as the pharmacy (with a prescription). 

What’s at stake? Money and control.

The number of rare therapies approved over the past two years has mushroomed. Most of the therapies have been $HUGE$ dollar meds that are hospital administered, often at leading national medical centers. These providers are very concerned about money and control. If they can buy directly and bill under often outdated, traditional contract terms (which never envisioned meds costing in the hundreds of thousands of dollars for a one-time infusion and may still pay them at U&C rates) then chances are they will realize a larger Net profit. If a specialty pharmacy is inserted into that scenario, they may not be able to realize any profit if the SP directly bills the PBM as a pharmacy claim or payer via a medical claim. 

It is no surprise that the hospitals are now upping the ante and turning to the courts and even state legislatures, where they may have significant influence, to seek relief and regain control. 

But…. who is the third party to this battle? Manufacturers.The pharmaceutical manufacturers proliferated the “White Bagging” war by selecting one or a handful of specialty pharmacies to be their preferred distributor(s) for these new infused therapies. Traditional distributors can’t perform all the functions of a specialty pharmacy as they are prohibited from making direct patient contact. Manufactures realized that SPs can help them out with managing patient care, ensuring compliance, tracking outcomes for FDA reporting, in addition to all the traditional SP patient stuff such as clearing prior authorizations and financial assistance. When payers and PBMs realized what was happening they got creative and saw a way to insert utilization review and tighter benefits management into the mix, things that SPs are also adept at juggling. 

It is also noteworthy to mention that SPs are also inventorying their meds for distribution. Traditional distributors charge manufacturers a percentage for their limited services…. better to pay an SP for the full-service package vs. just “park, pack, and ship.” 

So, it is surprising that the hospital lobby is focusing its ire only on the payers and PBMs, allowing the manufacturers off the hook. Then again, there are a lot of big research dollars that flow from manufacturers to the same big medical centers in new drug trials….. just sayin’. 

So, read the article below for a good update on what the leading payers are doing related to “White Bagging”.
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Payers Attempt to Impose “White-Bagging” Policies on Hospitals

CLICK HERE TO READ THE FULL ARTICLE

The FDA has approved a new INFUSED biologic, Vyvgart (efgartigimod alfa-fcab, Argenx), for treatment of generalized Myasthenia Gravis (gMG) in adults who are acetylcholine receptor antibody positive. gMG is a rare, chronic autoimmune, neuromuscular disease.

Myasthenia gravis is characterized by debilitating and potentially life-threatening muscle weakness and rapid fatigue of any of the muscles under voluntary control. The disease can affect people of any age and is more common in women younger than 40 and in men older than 60. Roughly 3 percent of people who develop gMG will die from it.

There is no cure for myasthenia gravis, but treatment can help relieve other signs and symptoms, such as double vision, drooping eyelids, and difficulties with speech, chewing, swallowing and breathing.

Prior to the approval of Vyvgart, therapies to control gMG include corticosteroids such as prednisone (Rayos), immunosuppressants (e.g., Azasan, Imuran), mycophenolate mofetil (Cellcept), cyclosporine (Sandimmune, Gengraf, others), methotrexate (Trexall) or tacrolimus (Astrograf XL, Prograf, others). Intravenous therapies incude plasmapheresis, intravenous immunoglobulin (IVIg), and monoclonal antibodies such as Rituximab (Rituxan) and eculizumab (Soliris).

The prevalence of gMG in the United States is estimated at 14 to 20 per 100,000 population, which translates into 36,000 to 60,000 cases in the United States. gMG has a low incidence rate of 2.1 to 5.0 per million people per year in the US.

Pricing for Vyvgart was not released upon approval. By reference, Soliris is currently priced at $675,000 per year. Distribution details were not released; however, it is presumed that Vyvgart will launch into limited distribution similar to Soliris.

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FDA approves Vyvgart for treatment of myasthenia gravis

The FDA announced the approval of Vygart for treatment of the chronic autoimmune, neuromusucal disease myasthenia gravis in adults who are positive for acetylcholine receptor antibody positive adults.

The approval of the investigational antibody fragment designed to target the neonatal Fc receptor is the first for the new drug class, according to a press release.

“There are significant unmet medical needs for people living with myasthenia gravis, as with many other rare diseases,” Billy Dunn, MD, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in the press release. “Today’s approval is an important step in providing a novel therapy option for patients and underscores the agency’s commitment to help make new treatment options available for people living with rare diseases.”

In a randomized, double-blind, placebo controlled, multicenter Phase 3 trial completed in 2020, patients with myasthenia gravis with acetylcholine receptor antibodies who received Vyvgart (efgartigimod, Argenx) responded to treatment at a higher rate as compared with placebo.

Since the therapy reportedly decreases levels of immunoglobulin, experts warn of an increased risk of infection. Hypersensitivity reactions are also possible, including eyelid swelling, shortness of breath, and rash. In the cases of hypersensitivity or existing infection, treatment should be either discontinued or delayed, according to the press release.

The FDA approved a new, subcutaneous biologic last week, Tezspire (tezepelumab-ekko) from Amgen and AstraZeneca, an add-on maintenance treatment for adult and pediatric patients (12+) with severe asthma. Tezspire is a first-in-class biologic for this complex condition.

Severe asthma impacts many of the 34 million people living with the disease worldwide. It affects their breathing and can severely limit day-to-day activity. The treatment has proven effective across a spectrum of causes of inflammation (but not indicated for acute bronchospasm or status asthmaticus).

Tezspire is the result of a collaboration agreement by Amgen and AstraZeneca that started in 2012. The companies will share costs and profits equally. AstraZeneca will lead development and Amgen will lead manufacturing. Amgen and AstraZeneca will jointly commercialize Tezspire in the US. Tezspire will enter the segment now led by Xolair (omalizaub) for patients with allergic asthma and Dupixent (dupilumab) for patients with eosinophilic asthma. Analysts forecast Teszpire to break the $$billion mark within three years of launch.

Tezspire will enter the market at an anticipated price of $28,000 per year. Distribution details were not released. Given that both Xolair and Dupixent are only available through limited distribution it is likely that Tezspire will also launch through LD.

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FDA Approves Tezspire (tezepelumab-ekko) in the U.S. for Severe Asthma

First and Only Biologic to Consistently and Significantly Reduce Exacerbations in a Broad Population of Severe Asthma Patients
Only Biologic for Severe Asthma Approved With no Phenotype or Biomarker Limitations

THOUSAND OAKS, Calif., Dec. 17, 2021 /PRNewswire/ — Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved Amgen and AstraZeneca’s Tezspire™ (tezepelumab-ekko) for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.1

Tezspire was approved following a Priority Review by the FDA and based on results from the PATHFINDER clinical trial program. The application included results from the pivotal NAVIGATOR Phase 3 trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.2

“Today’s approval by the FDA marks the first time that patients and their physicians will have a biologic option for severe asthma without phenotypic limitations and irrespective of biomarker levels,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “Asthma is a complex and chronic inflammatory disease that affects everyone differently. By working at the top of the inflammation cascade, Tezspire helps stop the inflammation that causes asthma attacks at the source and has the potential to treat a broad population of people with severe asthma, including those who have historically lacked effective treatment options.”

Tezspire acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine.3 It is the first and only biologic to consistently and significantly reduce asthma exacerbations across Phase 2 and 3 clinical trials, which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status and fractional exhaled nitric oxide (FeNO).2,3 Tezspire is the first and only biologic for severe asthma that does not have a phenotype—eosinophilic or allergic—or biomarker limitation within its approved label.4-11

“Due to the complex and heterogeneous nature of severe asthma and despite recent advances, many patients continue to experience frequent exacerbations, an increased risk of hospitalization and a significantly reduced quality of life,” said Professor Andrew Menzies-Gow, director of the Lung Division, Royal Brompton Hospital, London, UK, and the principal investigator of the NAVIGATOR trial. “Tezspire represents a much-needed new treatment for the many patients who remain underserved and continue to struggle with severe, uncontrolled asthma.”

Results from the NAVIGATOR Phase 3 trial were published in The New England Journal of Medicine in May 2021.2 In clinical studies of Tezspire, the most common adverse reactions were nasopharyngitis, upper respiratory tract infection and headache.