Drugs

Lilly Plans NDA for Obesity Pill; Positive Data Released

Eli Lilly says it will soon seek FDA approval for its investigational obesity pill orforglipron following its 8/26 release of “positive topline results” from the Phase 3 ATTAIN-2 trial that evaluated the oral GLP-1 receptor agonist in obese or overweight adults with Type 2 diabetes. “In the trial, all three doses of orforglipron met the primary and all key secondary endpoints, delivering significant weight loss, meaningful A1C reductions, and improvements in cardiometabolic risk factors at 72 week,” the company says. "For the primary endpoint, orforglipron 36 mg, taken once per day without food and water restrictions, lowered weight by an average of 10.5% (22.9 lbs) compared to 2.2% (5.1 lbs) with placebo using the efficacy estimand.”

The drug also improved blood sugar control, with hemoglobin A1C levels falling by as much as 1.8 percentage points from a baseline of 8.1%, Lilly says. Three-quarters of participants on the highest dose achieved an A1C at or below 6.5%, the American Diabetes Association’s threshold for diabetes, it adds.

Orforglipron’s safety profile was also in line with other GLP-1 drugs such as semaglutide, with gastrointestinal side effects like nausea, diarrhea, and vomiting being the most common complaints, according to Lilly. Rates of discontinuation due to side effects ranged from 6% to 11% across doses, similar to placebo.

Lilly notes it is also studying the pill in conditions linked to obesity, including sleep apnea and hypertension.

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

Read more

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