Drugs

Lilly Plans NDA for Oral Weight-Loss Drug

Eli Lilly plans to file an NDA by the end of the year for its investigational obesity treatment orforglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist, based on just-announced Phase 3 data showing the drug demonstrated significant weight loss. The ATTAIN-1 study enrolled 3,127 adults with obesity or who were overweight and at least one weight-related medical condition (except diabetes), according to the company. Over 72 weeks, all three orforglipron tested doses met the primary and all key secondary endpoints, delivering meaningful weight loss compared to placebo, it says.

Participants receiving the highest dose of orforglipron (36 mg) lost an average of 12.4% of their body weight (27.3 lbs), compared to 0.9% (2.2 lbs) in the placebo group, Lilly says. The highest also yielded improvements in cardiovascular risk markers, including reductions in triglycerides, non-HDL cholesterol, systolic blood pressure, and high-sensitivity C-reactive protein, which dropped by nearly 48%.

The safety profile of orforglipron was consistent with other GLP-1 receptor agonists, according to the company. Gastrointestinal issues were the most common side effects, including nausea (up to 36%), constipation, diarrhea, vomiting, and indigestion. Most cases were mild to moderate. Treatment discontinuation due to side effects ranged from 5.1% to 10.3% depending on the dose, compared to 2.6% with placebo. No liver safety concerns were reported.

Lilly plans to present detailed data from ATTAIN-1 at the European Association for the Study of Diabetes annual meeting in September and publish the findings in a peer-reviewed journal. Additional results from the broader ATTAIN program, as well as from the ACHIEVE program for people with Type 2 diabetes, are expected later this year.

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