Drugs

Eisai/Biogen Report ‘Promising’ Alzheimer’s Data

Eisai and Biogen are reporting new data from a lecanemab Alzheimer’s Phase 3 trial that suggest treated patients with early Alzheimer’s disease had reduced brain amyloid levels and moderately less decline on clinical measures of cognition and function than patients on placebo at 18 months, but they experienced more serious adverse events than those on placebo. “Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease,” researchers wrote in a NEJM article.

The Alzheimer’s Association was encouraged by the data from the CLARITY AD clinical trial, adding that it “confirms this treatment can meaningfully change the course of the disease for people in the earliest stages of Alzheimer’s disease.” The group called on FDA to finalize its ongoing review of the BLA and grant the companies accelerated approval.

The data were also presented by Eisai at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference in San Francisco 11/29, reporting that lecanemab treatment reduced clinical decline by 27% on the global cognitive and functional scale, compared with placebo. It also said treatment with lecanemab “showed statistically significant reduction in amyloid plaque burden at all timepoints starting at three months.”

On the safety side, researchers said serious adverse events occurred in 14.0% of the participants in the lecanemab group and 11.3% of those in the placebo group. The most commonly reported serious adverse events were infusion-related reactions (in 1.2% of the participants in the lecanemab group and 0 participants in the placebo group), amyloid-related imaging abnormalities with edema or effusions (in 0.8% and 0, respectively), atrial fibrillation (in 0.7% and 0.3%), syncope (in 0.7% and 0.1%), and angina pectoris (in 0.7% and 0).

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