Radar on Specialty Pharmacy
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New FDA Approvals: FDA Approves Pyrukynd
Feb. 17: The FDA approved Agios Pharmaceuticals, Inc.’s Pyrukynd (mitapivat) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency. It is a first-in-class, oral PK activator and the first FDA-approved disease-modifying therapy for the disease. The agency gave the drug priority review and orphan drug designation. Dosing for the tablet is 5 mg twice daily. Its annual cost is $334,880.
Feb. 21: The FDA gave an additional approval to Foundation Medicine, Inc.’s FoundationOne CDx as a companion diagnostic to identify people with microsatellite instability high status solid tumors who may be candidates for treatment with Merck and Co., Inc.’s Keytruda (pembrolizumab). The company says it is the first FDA-approved diagnostic for this use. The CDx has 26 companion diagnostic claims and two group claims across 27 targeted therapies.
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News Briefs: Teva Launches First Generic of Revlimid in U.S.
Teva Pharmaceuticals Ltd. launched the first generic version of Bristol Myers Squibb unit Celgene Corp.’s Revlimid (lenalidomide) in 5 mg, 10 mg, 15 mg and 25 mg strengths in the United States on March 7. The FDA approved the drug from Teva U.S. affiliate Arrow International Ltd. and Natco Pharma Ltd. on May 21, 2021. The companies have tentative approval for the 2.5 mg and 20 mg strengths due to an exclusivity issue: The FDA has approved Dr. Reddy’s Laboratories Ltd.’s lenalidomide for those dosages. The product is approved for three indications: (1) multiple myeloma in combination with dexamethasone, (2) transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality with or without additional cytogenic abnormalities and (3) mantle cell lymphoma that has relapsed or progressed after at least two treatments, including bortezomib. The launch is limited, and through an agreement with Celgene, the companies are allowed to sell “mid-single-digit percentages” of Revlimid’s total volume this month, a figure that gradually will increase to one-third of the volume. Beginning Jan. 31, 2026, Teva can sell the drug without volume limitation. Multiple companies are expected to launch Revlimid generics in the U.S. this year. -
2022 Outlook: Notable FDA Approvals, Payer Strategies Are Specialty Trends
The specialty pharmacy industry will continue its growth in 2022, experts tell AIS Health, a division of MMIT. Multiple agents for rare diseases are poised for FDA approval, and the market may see additional cell and gene therapies. In addition, payers will carry on their efforts to keep prices for specialty medications affordable, among other trends.
AIS Health: What are some specialty pharmacy issues to keep an eye on in 2022, and why?
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FDA Approves Novartis Drug That Will Go Up Against PCSK9s
More than a year after pandemic travel restrictions pushed back the FDA’s approval decision on Novartis Pharmaceuticals Corp.’s inclisiran, the agency finally approved it. The new first-in-class therapy targets so-called bad cholesterol and is set to compete with two other biologics that target the same protein.
On Dec. 22, the FDA approved Leqvio as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-c).
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Biosimilar Approvals Are Expected to Undergo Upward Trend in 2022
The FDA approved only four biosimilars in 2021, down from its high of the 10 it approved in 2019, but slightly more than the three such therapies approved in 2020. The agency also granted interchangeability to the first two biosimilars. This year may up the excitement level, industry experts tell AIS, a division of MMIT, with numerous products expected to be approved, while other noteworthy therapies will lose patent protection and potentially face biosimilar competition.
Dea Belazi, Pharm.D., M.P.H., president and CEO of AscellaHealth: The United States has been slow to approve and adopt biosimilars. Since the initial biosimilar approval in 2015, the FDA has approved 33 biosimilars, but only 18 are currently available on the U.S. market with a projected market value of $13 billion in 2021. Even with this slow uptake in the United States, there is increased utilization and a growing pipeline of products that will drive use and savings. In 2021, many blockbuster drugs were approved in the biosimilar space, along with the two interchangeable biosimilar products, [Boehringer Ingelheim Pharmaceuticals, Inc.’s] Cyltezo and [Viatris Inc. and Biocon Ltd. subsidiary Biocon Biologics Ltd.’s] Semglee.
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