Biologics

Biogen Abandoning Aduhelm in Alzheimer’s Re-focus

Biogen says it is discontinuing the further development and commercialization of controversial Alzheimer’s drug Aduhelm (aducanumab-avwa) 100 mg/mL injection for intravenous use as part of a move to reprioritize its resources in the disease space.

Aduhelm’s 2021 approval was met with public concern and outrage, much of it focused on FDA’s unusual turn to accelerated approval after an advisory committee voted down Biogen’s study data being considered for traditional approval (see earlier story). Interestingly, panel members were not asked for their input on whether accelerated approval was a viable option. Shortly after the drug’s approval and to protest FDA’s irregularities, three of the panel members resigned (see story)

A subsequent investigation by two House committees culminated in a 12/30/2022 report that was sharply critical of the approval and the agency’s decision to work so closely with the company to guide the drug’s review and approval. The report found FDA’s interactions with Biogen were atypical and that the agency had deviated from its own guidance on documenting meetings with industry.

Biogen now says it will continue to advance Alzheimer’s therapy Leqembi (lecanemab-irmb), which was converted from accelerated approval to full approval last July. Leqembi works by reducing amyloid plaques that form in the brain, which FDA says is a “defining pathophysiological feature of the disease.” Additionally, Biogen says it will “accelerate development of potential new treatment modalities, including its ASO targeting tau (BIIB080) and an oral small molecule inhibitor of tau aggregation (BIIB113).”

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