From the start of the Nov. 16 Oncologic Drugs Advisory Committee meeting, the U.S. FDA made it clear that withdrawing Acrotech Biopharma Inc.’s peripheral T-cell lymphoma drugs, Folotyn (pralatrexate) and Beleodaq (belinostat), from the market until a long-overdue confirmatory trial is completed is not an option given the current treatment landscape.
The U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee has a lot to discuss Nov. 17, but only one voting question: Does the evidence demonstrate that Merck & Co. Inc.’s gefapixant provides a clinically meaningful benefit to adults with refractory or unexplained chronic cough?
If everything goes according to the current plan, the U.S. FDA would get the final report of a confirmatory trial for Acrotech Biopharma Inc.’s Folotyn (pralatrexate) and Beleodaq (belinostat) in 2030 – more than two decades after Folotyn received accelerated approval to treat relapsed or refractory peripheral T-cell lymphoma and 16 years after Beleodaq was granted accelerated approval for the same indication.
Carrying through on a policy it adopted a few months ago to crack down on potentially anticompetitive FDA Orange Book listings, the U.S. FTC put 10 drug companies on notice that it’s challenging several of their “improperly or inaccurately listed” patents through the FDA’s regulatory dispute process.
In another step that blurs the distinction between biosimilars and interchangeables, the U.S. Centers for Medicare & Medicaid Services (CMS) is proposing a rule to give Medicare Part D plans more flexibility to substitute biosimilars for the reference biologics so Medicare beneficiaries can have timelier access to the lower-cost drugs. The rule would permit the plans to treat the biosimilar substitutions as “maintenance changes” that don’t require prior Medicare approval. Such changes would enable the substitutions to apply to all enrollees – and not just those who begin the therapy after the effective date of the change.
Wading into the “muddied waters” of rounding the numbers used in a range claimed in two drug patents, the U.S. Court of Appeals for the Federal Circuit refused to set a “bright line rule.” Instead, it tossed a lower court win for Actelion Pharmaceuticals Ltd. against Mylan Pharmaceuticals Inc. and sent the case back to that court with instructions to consider the extrinsic evidence and its impact on the claim construction.
After nearly two years with an acting director, the U.S. NIH now has a confirmed leader. The Senate voted 62-36 Nov. 7 to confirm Monica Bertagnolli, a cancer surgeon and researcher, as the next director of the research agency.
Instead of the two-step process that’s been the typical path for interchangeables in the U.S., Amgen Inc.’s Wezlana got a green light Oct. 31 from the FDA as both the first approved biosimilar and interchangeable to Johnson & Johnson’s inflammatory disease drug, Stelara (ustekinumab).
Had it been asked to, the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee would have voted Oct. 31 to recommend approval of Vertex Pharmaceutical Inc. and Crispr Therapeutics AG’s exagamglogene autotemcel, or exa-cel, as a one-time transformative treatment for severe sickle cell disease in individuals 12 and older.
