Drugs

Lilly's Oral GLP-1 Outperforms Oral Semaglutide in Diabetes Trial

Eli Lilly is reporting detailed Phase 3 results Monday showing its oral GLP-1 receptor agonist Foundayo (orforglipron) outperformed Novo Nordisk's oral semaglutide on blood sugar control and weight loss in what the company described as the first head-to-head late-stage trial comparing two oral GLP-1 therapies for Type 2 diabetes.

The findings, presented at the American Diabetes Association Scientific Sessions, come as Lilly prepares to submit Foundayo to FDA for a Type 2 diabetes indication by the end of the month under the agency's National Priority Review Voucher program.

Lilly says the Phase 3 ACHIEVE-3 study, which enrolled 1,698 adults with Type 2 diabetes inadequately controlled on metformin. At 52 weeks, patients receiving Foundayo's highest dose of 17.2 mg achieved a 2.2 percentage-point reduction in A1C compared with a 1.4 percentage-point reduction for oral semaglutide 14 mg. Lilly said the result represented a 57.1% greater relative reduction in A1C.

Weight-loss results also favored Foundayo. Patients receiving the 17.2 mg dose lost an average 19.7 pounds, or 9.2% of body weight, compared with 11 pounds, or 5.3% of body weight, among those receiving oral semaglutide 14 mg. Lilly calculated the difference as a 73.6% greater relative weight reduction.

Lilly also released detailed results from two additional Phase 3 studies.

The data strengthen Lilly's effort to establish Foundayo as a leading oral incretin therapy in a market currently dominated by injectable GLP-1 agents and Novo Nordisk's oral semaglutide product, Rybelsus.

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