Drugs

Eisai/Biogen Claim Lecanemab Trial Success

Eisai and Biogen say the Phase 3 confirmatory Clarity AD trial of their lecanemab (BAN2401), an investigational anti-amyloid beta protofibril antibody to treat mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease with confirmed presence of amyloid pathology, successfully met all primary and secondary endpoints. A statement says the companies plan to file for traditional FDA approval by 3/31/23. They have already submitted a BLA for accelerated approval of lecanemab, which FDA accepted in July. The PDUFA action date on the BLA is 1/6/23.

The statement says the primary and secondary endpoints were met with “highly statistically significant results.”

Eisai and Biogen say FDA has agreed that the results of Clarity AD can serve as the confirmatory study to verify lecanemab’s clinical benefit.

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