Drugs

Amylyx to File NDA Based on Positive Phase 3 Results for Avexitide

Amylyx Pharmaceuticals says it will file an NDA by the end of the year for its investigational drug avexitide after new data show significantly reduced hypoglycemic events in a Phase 3 clinical trial involving patients with post-bariatric hypoglycemia (PBH).The company just reported topline results from the 78-participant LUCIDITY trial evaluating avexitide in adults who developed PBH following Roux-en-Y gastric bypass surgery.

The trial met its FDA-agreed primary endpoint, with avexitide producing a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared with placebo through Week 16. LUCIDITY also met all secondary endpoints, demonstrating statistically significant reductions in Level 2 hypoglycemic events measured through self-monitoring of blood glucose and continuous glucose monitoring, as well as Level 3 hypoglycemic events independently adjudicated by investigators.

PBH is described as a chronic metabolic complication that can occur after bariatric surgery and is characterized by recurrent episodes of low blood glucose, often occurring after meals. Severe hypoglycemia can result in cognitive impairment, loss of consciousness, seizures and the need for assistance from another person.

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