Novo Nordisk submits application for FDA approval of CagriSema for weight management

Novo Nordisk has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for CagriSema, a once-weekly injectable treatment aimed at managing weight in adults with obesity or overweight. The treatment combines cagrilintide 2.4 mg, a long-acting amylin analogue, with semaglutide 2.4 mg, a GLP-1 receptor agonist. If approved, CagriSema would be used alongside a reduced-calorie diet and increased physical activity to help individuals achieve and maintain long-term weight reduction.

A New Approach to Addressing Obesity

CagriSema is designed to provide a novel, fixed-dose combination therapy aimed at addressing obesity and its related complications. According to Novo Nordisk, the submission is supported by findings from the REDEFINE clinical trial program, which demonstrated the treatment’s safety and efficacy in clinical settings.

"The FDA submission of CagriSema marks an important milestone and signals a new era in weight management, reinforcing Novo Nordisk’s long-standing commitment to serving people living with obesity through innovation and science", said Mike Doustdar, president and CEO of Novo Nordisk. "Building on the well-established profile of semaglutide and combining it with a novel mechanism of action, CagriSema has the potential to represent a meaningful step forward in the holistic treatment of obesity. With our leadership in metabolic disease, we are encouraged by the promise of this first-in-class combination to expand treatment options and address the evolving needs of patients."

Clinical Trial Results Highlight Effectiveness

The NDA is based on data from two Phase 3 trials, REDEFINE 1 and REDEFINE 2, which together involved over 4,600 participants. In the REDEFINE 1 trial, which included adults with obesity or overweight and weight-related complications (excluding diabetes), participants treated with CagriSema experienced significant weight loss. Over 68 weeks, individuals using CagriSema achieved a weight loss of 20.4% on average, compared to 3.0% in the placebo group. When analyzing outcomes among participants who adhered to the treatment throughout, weight loss increased to 22.7%, compared to 2.3% for placebo.

The study also revealed that approximately 91.9% of participants using CagriSema achieved at least a 5% reduction in body weight, compared to 31.5% in the placebo group. Furthermore, 54% of participants with obesity reached a body mass index (BMI) below 30, effectively moving out of the obesity category, compared to just 11.1% in the placebo group.

The REDEFINE 2 trial focused on participants with type 2 diabetes and coexisting obesity or overweight. Both trials demonstrated that CagriSema’s safety profile was consistent with the GLP-1 receptor agonist class.

Mike Doustdar emphasized the importance of this treatment option, stating, "This submission reflects the continued advancement of Novo Nordisk’s obesity pipeline and our focus on translating scientific innovation into patient-relevant outcomes. If approved, CagriSema would provide patients and healthcare professionals with an additional treatment option supported by results from the REDEFINE clinical program, including powerful efficacy, high treatment completion rates, and a tolerability profile consistent with its underlying pharmacology. We believe these data underscore the potential of CagriSema to address unmet medical needs in obesity and support long-term disease management."

Next Steps

The FDA is expected to review the application in 2026. If approved, CagriSema could become a vital tool for healthcare providers and patients seeking innovative solutions for managing obesity and its associated health challenges.

Novo Nordisk’s submission reflects its commitment to expanding treatment options for metabolic conditions and addressing the growing prevalence of obesity worldwide.

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