Drugs

Panel Backs Full Approval of Alzheimer’s Drug

FDA’s Peripheral and Central Nervous Systems Drugs Advisory Committee 6/9 voted 6 to 0 that data from the Phase 3 CLARITY AD trial verified the clinical benefit of Eisai/Biogen’s Leqembi (lecanemab) in the early treatment of Alzheimer’s disease. Eisai received accelerated approval for Leqembi 1/6 and was required to conduct a postmarketing clinical trial verifying and describing the anticipated Leqembi clinical benefit. The primary safety issues identified in the study are amyloid-related imaging abnormalities, cerebral hemorrhage, and infusion-related reactions and hypersensitivity.

Panel members agreed that the study met its primary endpoint and also showed significant treatment effects in secondary endpoints. In voting yes, panel acting chair and University of Arizona College of Medicine professor Robert C. Alexander said lecanemab’s overall benefit-risk assessment was favorable. “There are adverse events associated with the candidate treatment, some of them can be quite serious, but they're monitorable.”

FDA has set a 7/6 user fee review action target date to render a final decision on whether to grant full approval, which would trigger Medicare coverage almost immediately. Coverage was not available under accelerated approval (see earlier story).

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome