Drugs

New Lilly Drug Meets Endpoints on Weight Loss

Eli Lilly says new Phase 2 data on weight-loss candidate retatrutide met primary and secondary endpoints. After 24 weeks, it met the primary endpoint by demonstrating a mean weight reduction up to 17.5% (41.2 lb. or 18.7 kg), the company says. In meeting the secondary endpoint, the drug demonstrated a mean weight reduction up to 24.2% (57.8 lb. or 26.2 kg) after 48 weeks of treatment. Previously, Lilly reported it was going to seek approval for diabetes drug Mounjaro (tirzepatide) for use in adults with obesity or who are overweight with weight-related comorbidities after reporting up to 15.7% weight loss in clinical trials (see story).

“We believe that combining glucagon receptor agonism with GIP and GLP-1 receptor agonism may be one of the reasons retatrutide showed this level of weight reduction,” Lilly chief scientific officer Dan Skovronsky is quoted in a release as saying. “These Phase 2 data have given us confidence to further explore the potential of retatrutide in Phase 3 trials that will look beyond weight reduction and focus on treating obesity and its complications comprehensively.” Lilly says its TRIUMPH Phase 3 development program (four clinical trials) is evaluating the safety and efficacy of retatrutide for chronic weight management, obstructive sleep apnea, and knee osteoarthritis in those who are obese and overweight.

Additionally, Lilly says the drug’s safety is similar to other incretin-based therapies. “Gastrointestinal side effects were the most commonly reported adverse events, were generally mild-to-moderate in severity, and usually occurred during the dose escalation period,” 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