Drugs

Biogen to File Alzheimer’s Confirmatory Trial Protocol

Biogen says it will submit to FDA in 3/2022 a final clinical trial protocol for a required post-marketing trial of its controversial Alzheimer’s drug Aduhelm (aducanumab). Aduhelm was granted accelerated approval earlier this year amid a firestorm of criticism over the agency’s use of the pathway for an Alzheimer’s indication (see earlier story). Three FDA advisory committee members who were on a panel that voted 10-0-1 last November not to recommend the drug’s approval have resigned their agency posts in protest.

As part of its approval, FDA is requiring a post-marketing confirmatory trial that will assess the therapy’s safety and effectiveness. Biogen says it is planning a global, placebo-controlled trial that aims to enroll more than 1,300 early Alzheimer’s disease patients, with a primary clinical endpoint at 18 months after treatment initiation. Based on enrollment rates from the previous Phase 3 trials, the primary completion date is expected to be about four years after the study begins, targeted for 5/2022. The trial will also include a long-term extension to collect longer-term treatment data for up to 48 months.

Aduhelm is a monoclonal antibody directed against amyloid beta. “The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer’s disease,” Biogen says. The accelerated approval was granted on data from clinical trials showing the drug’s effectiveness in reducing amyloid beta plaque, a surrogate biomarker that is reasonably likely to predict clinical decline.

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