Drugs

Eisai/Biogen Get Fast Track for Alzheimer’s Therapy

FDA has granted Eisai and Biogen a fast track designation for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for treating early Alzheimer’s disease. In 9/2021, Eisai initiated a rolling BLA submission under the accelerated approval pathway based on clinical, biomarker and safety data from a Phase 2b clinical study (Study 201) in people with early Alzheimer’s and confirmed amyloid pathology, according to the companies.

“The lecanemab Phase 2b study results demonstrated a high degree of Aβ plaque lowering and consistent reduction of clinical decline across several clinical endpoints.” the companies say. “The correlation between the extent of Aβ plaque reduction and effect on clinical endpoints in Study 201 further supports Aβ as a surrogate endpoint that is reasonably likely to predict clinical benefit.”

An 1,800-patient Phase 3 study (Clarity AD) is ongoing, and FDA reportedly has agreed that the results can serve as the confirmatory study to verify lecanemab’s clinical benefit. Another Phase 3 clinical study, AHEAD 3-45, is evaluating the therapy’s efficacy in participants with preclinical Alzheimer’s and elevated amyloid and in participants with early preclinical Alzheimer’s and intermediate amyloid, the companies say.

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