Drugs

FDA OKs Updated Dosing for Lilly’s Alzheimer's Drug

FDA has approved an updated dosing schedule for Eli Lilly’s Alzheimer’s therapy Kisunla (donanemab-azbt), aimed at reducing the risk of a known side effect called amyloid-related imaging abnormalities with edema (ARIA-E). Approved 7/2024 as a once-monthly infusion therapy targeting amyloid plaques in the brains of people with early symptomatic Alzheimer’s, Kisunla’s now-updated prescribing information includes a modified titration schedule that gradually increases the dose over time, Lilly says.

Data from Lilly’s TRAILBLAZER-ALZ 6 clinical trial showed that the dosing change led to a significantly lower incidence of ARIA-E while maintaining the drug’s effectiveness, it says. In the study, the new dosing approach reduced ARIA-E incidence by 41% at 24 weeks and 35% at 52 weeks compared to the original regimen. ARIA-E, though often asymptomatic, can sometimes lead to serious or even fatal complications and has been a safety concern for all drugs in this class.

Lilly also says the trial found that the new schedule preserved Kisunla’s ability to reduce both amyloid plaques and the Alzheimer’s-related biomarker P-tau217. After 24 weeks, patients on the modified titration showed a 67% reduction in amyloid plaque, compared to 69% for those on the original schedule, it says.

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