Despite a busy September, U.S. FDA approvals and global regulatory news fell in October to the lowest point this year. So far in 2022, the FDA has approved 127 drugs and biologics, including supplemental filings. This is 25% less than each of the last two years, which had 170 approvals in 2021 and 169 approvals in 2020 through the end of October. The last time approvals were lower than this year was 2016 when there were 121.
Reflecting statutory and regulatory requirements added over the past five years, the U.S. FDA is issuing a revised draft question-and-answer (Q&A) guidance on expanded access to investigational drugs. One of several guidances recently issued, the 40-page draft incorporates requirements from the 21st Century Cures Act and the 2017 FDA Reauthorization Act that took effect after the current final Q&A guidance was updated in 2017. It also answers new questions sponsors have raised over the past few years.
The U.S. FDA announced that it has cleared a new set of tubes used in hemodialysis machines made by Fresenius Medical Care AG & Co., of Bad Homburg, Germany, that are expected to overcome concerns about the previous tubes’ release of potentially toxic biphenyls. The agency acknowledged that it has no reports of adverse events related to the use of these chemicals in the silicone used to manufacture the tubes, stating that its action on this issue is driven solely by animal studies in the medical literature, none of which were cited in the FDA’s Oct. 28 announcement.
Simcere Pharmaceutical Group announced that the FDA has cleared the company’s IND application for SIM-0237 for the treatment of adult patients with advanced solid tumors.
Ascletis Pharma Inc. announces that the company has filed an IND application with the FDA for ASC-10, an oral antiviral drug candidate targeting viral polymerase of monkeypox virus.
Novaccess Global Inc. has announced the approval of its application with the FDA for orphan drug designation for TLR-AD1, a vaccine immunotherapy for the treatment of aggressive brain cancers, including glioblastoma and other high-grade gliomas. The company’s therapeutic path involves a unique transformational process, which involves the addition of proprietary substances to create a cocktail for more personalized treatment that substantially increases clinical benefits for patients.
Briefing documents related to the Oct. 28 meeting of the Oncologic Drugs Advisory Committee (ODAC) to deliberate over Y-mabs Therapeutics Inc.’s Omblastys (131I-omburtamab) took aim at the company’s ongoing, pivotal experiment called Study 101, data from which the company highlighted in early October.
The U.S. FDA cleared teclistamab from Janssen Pharmaceutical Cos. as the first bispecific antibody for treating patients with relapsed or refractory multiple myeloma (MM), joining other BCMA-targeted drugs, including an antibody-drug conjugate and CAR T therapies.
GSK plc may have pushed the door open Oct. 26 for the use of a new class of oral drugs to treat anemia in U.S. patients with chronic kidney disease who are dialysis dependent. The U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 13-3 that the benefits of GSK’s daprodustat outweighed the risks in that population. However, the committee didn’t push the door wide enough for patients not on dialysis, voting 5-11 on the question of whether the drug’s benefits outweighed its risk in the nondialysis population, even though that group conceivably could see a greater benefit. The test now is whether the FDA will follow the committee’s lead.
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