Biologics

Physicians Seek Panel Review for ‘Full Approval’ of Alzheimer’s Drug

Physician advocacy group Doctors for America is urging FDA to commit to convening an advisory committee meeting when it is time to consider the full approval of Biogen/Eisai’s Alzheimer’s therapy Leqembi (lecanemab).The group says it was concerned about the recent FDA decision to “expeditiously approve lecanemab despite reported patients deaths associated with the drug.” There are also questions about whether the surrogate endpoint used as the basis for accelerated approval, beta amyloid, is truly “reasonably predictive” of clinical benefit “despite over two dozen studies not finding such an association.”

Last week, Public Citizen unsuccessfully called on FDA to postpone its accelerated approval decision until after an advisory committee reviews the data and votes on its risk-benefit profile. In a 1/5 letter from Public Citizen’s Health Research Group founder and now-senior advisor Sidney Wolfe, the group said FDA’s decision to not convene an advisory committee demonstrates that the agency is “unwilling or unable to learn from its worst approval mistake” — Biogen’s Alzheimer’s therapy aducanumab (Aduhelm).

A Congressional report released 12/21 on FDA’s controversial review and approval of Aduhelm (see story) was sharply critical of the agency’s decision to work so closely with the company to guide the drug’s review and approval. “It seems the unprecedented aducanumab FDA/Biogen axis is still in place,” Wolfe argued in advocating for the panel meeting to protect the approval decision from being perceived as “yet another Biogen/FDA done deal.”

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