Drugs

Anselamimab Trial Misses Primary Endpoint in Amyloidosis

A Phase 3 clinical trial evaluating Alexion’s anselamimab for light chain (AL) amyloidosis failed to meet its primary endpoint in the overall study population, but showed significant clinical benefit in a predefined subgroup of patients, according to just-released topline results.

The Cardiac Amyloid Reaching for Extended Survival (CARES) study enrolled 406 patients across 19 countries, according to a release from parent company Astrazeneca. While the treatment did not achieve statistical significance for the composite primary endpoint — a combination of time to all-cause mortality and frequency of cardiovascular hospitalizations — "results from a predefined subgroup suggest that anselamimab may address a leading cause of organ damage and functional impairment in these patients," the company says. (X

Anselamimab is designed to target and remove toxic amyloid fibrils that accumulate in organs, particularly the heart and kidneys, in patients with AL amyloidosis — a rare and progressive disorder that affects an estimated 74,000 people globally and is often diagnosed late with a poor prognosis, according to the company. The evaluation of full results is ongoing, and Alexion plans to share these data with global health authorities and present them at an upcoming medical meeting.

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