Novo submits its next-gen obesity drug for FDA approval

Novo Nordisk is seeking FDA approval for its next-generation obesity drug, CagriSema, the company announced yesterday.

The move to file a New Drug Application (NDA) comes as Novo fights to regain its dominance in the booming obesity market, which is projected to reach $150 billion by the end of the decade.

CagriSema combines cagrilintide -- a dual amylin/calcitonin receptor agonist-- and semaglutide, the main active ingredient found in Novo's FDA-approved GLP-1 drugs Wegovy and Ozempic.

"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," president and CEO of Novo Nordisk Mike Doustdar said in a news release.

Combination and multiple agonist drugs that target additional metabolic pathways are emerging as promising next-gen weight loss options, as early data suggests they may help patients shed more weight and cause fewer or less severe side effects than commonly used GLP-1s.

CagriSema's NDA draws on data from Novo's Redefine 1 study, in which Novo's combination therapy led to a 20.4% mean weight loss after 68 weeks. Overall, 91.9% of participants lost at least 5% of their body weight, compared with 31.5% in the placebo arm. Over half reached a BMI under 30, versus 11.1% of those given a placebo.

In addition to obesity, CagriSema is being researched in adults with type 2 diabetes, cardiovascular conditions, chronic kidney disease and alcohol-related liver disease.

The Danish drugmaker is also planning to launch a phase 3 trial next month, testing CagriSema in more than 450 children and adolescents across 24 countries.

The FDA is expected to review CagriSema's NDA in 2026. If approved, CagriSema would be the first treatment that combines an injectable GLP-1 receptor agonist with an amylin analogue, the company says.

Novo Nordisk is also currently awaiting FDA approval for the pill version of its blockbuster weight loss drug, Wegovy, which is expected before the year is over.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.