The filing comes as Novo fights tooth-and-nail with rival Lilly to regain its footing at the top of the weight loss market.
Novo Nordisk has filed a new drug application with the FDA for its once-weekly injectable obesity drug CagriSema, another lap in a heated race with rival Eli Lilly, whose own assets are racking up clinical wins in the $27 billion obesity market.
The filing covers the use of the drug in adults who have obesity or are overweight with at least one weight-related comorbidity, according to an announcement Thursday.
CagriSema is a combination of a long-acting amylin analogue, cagrilintide, and Novo’s GLP-1 receptor agonist semaglutide, already approved as Wegovy for obesity and Ozempic for diabetes. Novo touted CagriSema in its announcement as potentially the first injectable amylin-GLP-1 combination therapy on the market.
“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,” CEO Maziar Mike Doustdar said in a statement.
The filing is based on results from Novo’s Phase III REDEFINE 1 trial. In December 2024, a readout from REDEFINE 1 showed CagriSema elicited 20.4% weight loss after 68 weeks, versus 11.5% with cagrilintide alone, 14.9% with semaglutide alone and 3% for the placebo group.
Another readout from the same REDEFINE 1 trial in June of this year saw 12% of patients reporting injection-site reaction adverse events. The cagrilintide component of the combination seemed to be at fault, as 17% on the amylin analogue alone reported the same events, versus 2.6% of patients who received semaglutide monotherapy. Analysts zeroed in on those reactions, noting that CagriSema’s efficacy seemed comparable to Eli Lilly’s GLP-1 Zepbound, though Lilly’s drug did not raise the same reactions.
In September, the company reported 11.8% weight reduction in patients who received CagriSema versus 2.3% for those in the placebo arm. Novo called the drug well-tolerated, with just 1% of patients who received it dropping out, compared to 0.1% in the placebo arm.
Novo is in a head-to-head battle with Eli Lilly to reclaim the obesity market. The Danish pharma is also awaiting a decision from the FDA on its oral semaglutide pill, due by the end of the year. Meanwhile, Lilly announced Thursday that its oral offering orfoglipron hit a key milestone, maintaining weight loss in patients who switched from Wegovy or Lilly’s GLP-1 Zepbound.
Lilly is also awaiting a decision from the FDA on a filing for orforglipron sometime in early 2026, though a Commissioner’s National Priority Voucher could move up that timeline.
