Drugs

Lilly’s Oral Diabetes Drug Outperforms Rival in Head-to-Head Trial

Eli Lilly says its investigational oral diabetes drug orforglipron achieved stronger blood sugar and weight loss results than Novo Nordisk’s oral semaglutide in a large late-stage head-to-head study. In the 52-week ACHIEVE-3 Phase 3 trial, orforglipron cut average A1C levels — a key measure of blood sugar control — by as much as 2.2 percentage points, compared with a 1.4-point reduction for the highest dose of oral semaglutide, the company says. Participants on the highest dose of orforglipron also lost an average of 19.7 pounds (9.2% of body weight), nearly double the 11 pounds (5.3%) shed by those on semaglutide, it adds.

Lilly says that beyond blood sugar and weight loss, orforglipron also demonstrated improvements in cardiovascular risk factors such as cholesterol, blood pressure and triglycerides. It adds that the safety profile of orforglipron was consistent with earlier studies. Gastrointestinal side effects were the most common and typically mild to moderate, and discontinuation rates due to side effects were slightly higher than with semaglutide (about 9% vs. 5%).

Lilly plans to present full results from the trial at a future medical meeting and submit orforglipron for regulatory approval next year.

Orforglipron is part of Lilly’s broader ACHIEVE clinical program, which is also evaluating it for weight management, obstructive sleep apnea, and hypertension in adults with obesity.

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