Drugs

Novo Nordisk Files CagriSema NDA for Weight Loss

Novo Nordisk has submitted an NDA to FDA for once-weekly CagriSema (cagrilintide 2.4 mg and semaglutide 2.4 mg) injection to be used with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long-term in adults with obesity or overweight in the presence of at least one weight-related comorbid condition. A company statement says that if the NDA is approved, CagriSema would be the first injectable GLP-1 receptor agonist and amylin analogue combination treatment. (Semaglutide is the active ingredient in the company’s blockbuster drugs Ozempic and Wegovy.)

The statement says the NDA is based on results from REDEFINE 1, a 68-week Phase 3 placebo- and active-controlled clinical trial evaluating the efficacy and safety of once-weekly CagriSema compared to semaglutide 2.4 mg alone, cagrilintide 2.4 mg alone, or placebo, all as an adjunct to lifestyle intervention in 3,417 adults with obesity or overweight with one or more obesity-related comorbid complications and without diabetes, and REDEFINE 2, a 68-week Phase 3 placebo-controlled trial that evaluated the efficacy and safety of once-weekly CagriSema versus placebo as an adjunct to lifestyle intervention in 1,206 adults with type 2 diabetes and either obesity or overweight.

In REDEFINE 1, the company says, those treated with CagriSema achieved weight loss of 20.4% at 68 weeks versus 3% for the placebo group, which was statistically significant. Safety data generated in both trials were comparable with the GLP-1 RA class, the notice says. Discontinuation rates due to adverse events were low, Novo Nordisk says, with adverse events mainly gastrointestinal, including nausea, constipation, and vomiting.

The company says it expects FDA to review the NDA in 2026.

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