Nearly a year and a half after Francis Collins stepped down as director of the U.S. NIH, President Joe Biden announced May 15 his intent to nominate Monica Bertagnolli as the next NIH director.
To the chagrin of some and the joy of others, the U.S. Supreme Court denied cert to Teva Pharmaceuticals USA Inc. v. Glaxosmithkline May 15, leaving standing a split Federal Circuit decision that could threaten the use of FDA-approved label carve-outs, or so-called skinny labels, for generics and biosimilars.
The U.S. FDA has approved a non-hormonal treatment from Astellas Pharma Inc. to reduce the number and severity of hot flashes. Veozah (fezolinetant), an oral, once-daily compound that targets the neurokinin-3 (NK3) receptor, is approved for treating moderate to severe vasomotor symptoms due to menopause. It’s the first NK3 receptor antagonist the FDA has greenlighted for the indication. The approval came on May 12, well before its May 22 PDUFA date. The PDUFA date was originally set for Feb. 22 but the FDA extended it, saying it needed more time to complete the NDA’s priority review. Veozah’s wholesale acquisition cost is $550 for a month’s supply and should be available by early June.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ani, ARS, Bloomsbury Genetic Therapies, Byondis, Clearmind, Decibel, Hefei Tianhui, Immpact, Innovent, Lianbio, Novavax, Nuvectis, Oramend, Pyxis, Regeneron, Sisaf.
The debate over Sarepta Therapeutics Inc.’s gene transfer therapy, SRP-9001 (delandistrogene moxeparvovec), in Duchenne muscular dystrophy (DMD) proved as thorny as expected during a closely watched meeting of the U.S. FDA’s Cellular, Tissue and Gene Therapies Advisory Committee. Panelists voted on a single question: “Do the overall considerations of benefit and risk, taking into account the existing uncertainties, support accelerated approval of SRP-9001, using as a surrogate endpoint expression of Sarepta’s microdystrophin at week 12 after administration, for the treatment of ambulatory patients with DMD with a confirmed mutation in the DMD gene?” Balloting turned out 8 yes, 6 no.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cytoagents, Immunitybio, Lundbeck, Mindbio, Otsuka, Soligenix.
Despite congressional concerns about accelerated approval, the U.S. FDA’s use of the pathway is not slowing down. If anything, it’s picked up pace since Congress gave the agency stronger authority last year to monitor drugs approved based on a surrogate endpoint and to ensure that confirmatory trials are progressing in a timely way.
Centricity Vision Inc. received U.S. FDA clearance for technology designed to integrate with modern phacoemulsification or “phaco” systems that use ultrasound energy to emulsify the eye's native internal lens during cataract surgery. Centricity’s new Zeptolink interocular lens (IOL) positioning system is used in conjunction with phaco systems to surgically remove the natural lens of the eye as the first step in cataract surgery.
Most of the decisions arising from the inter partes review (IPR) process used in the U.S. patent system are the final word on the related patent dispute, but Guardant Health Inc., managed to at least temporarily reverse such an outcome recently. The Court of Appeals for the Federal Circuit reversed an IPR determination that 16 claims found in a patent held by Guardant were obvious and kicked the case back to the Patent Trial and Appeal Board (PTAB) for further consideration, but the affected patent is not clear of an adverse determination just yet.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Invivoscribe.
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