Drugs

Promising Trial Results for Wegovy Add-on: Veru

Veru is announcing positive topline results from its Phase 2b QUALITY clinical trial that is evaluating the safety and efficacy of enobosarm in older patients using semaglutide (Novo Nordisk’s Wegovy) for chronic weight management. The company says the drug combination aims to enhance fat loss while preventing muscle loss that is frequently associated with GLP-1 receptor agonist treatments.

Veru reports that enobosarm and semaglutide combination demonstrated a favorable safety profile across both tested doses (3mg and 6mg). No drug-induced liver injury, increases in prostate-specific antigen, or reports of masculinization or suicidal ideation were observed, it says, adding that there were no treatment-related serious adverse events occurred during the study.

Veru previously shared positive efficacy outcomes from the QUALITY trial, which showed that the combination significantly reduced lean mass loss at 16 weeks. The 3mg enobarsam dose showed the most promise, with a 99.1% relative reduction in lean mass loss compared to semaglutide alone, it says.

Regarding next steps, Veru says it has requested an End of Phase 2 meeting with FDA. A proposed Phase 3 study will mirror the Phase 2b design and target older adults with obesity or overweight using GLP-1 receptor agonists like Wegovy. The primary endpoint will be improvement in physical function, with secondary endpoints including lean mass, fat mass, insulin resistance, and hemoglobin A1c, it adds.

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