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Jump to Key Points Sept 21 (Reuters) - Novo Nordisk said on Monday its next-generation experimental drug, CagriSema, delivered an estimated average weight loss of 12.4% in a late-stage trial in patients with diabetes, outperforming Eli Lilly's rival drug.
It has been viewed as a successor to Novo's blockbuster weight-loss drug, Wegovy, which faces patent expiries after 2030, and could help the Danish drugmaker claw back ground lost to Lilly in the fast-growing weight-loss market.
In a head-to-head trial earlier this year, the drug fell short of Lilly's Zepbound on weight loss, marking a setback for Novo.
CagriSema is a weekly injection that combines cagrilintide, which mimics pancreatic hormone amylin, and semaglutide, the active ingredient in Wegovy.
- CagriSema 1 mg: est wt loss 12.4% in late-stage T2DM trial.
- Weight loss > tirzepatide 5 mg; blood glucose lowering noninferior.
- Separate obesity trial: 1.0 mg CagriSema produced 21% wt loss vs placebo.
- Weekly injection combines cagrilintide + semaglutide.
- FDA decision for weight-management indication expected Q4.
At Novo's capital markets day on Monday, the company detailed a multi-year rollout for its next-generation obesity injectables, targeting a launch of its CagriSema combination early next year.
Novo's U.S.-listed shares were down more than 4% before the bell as analysts questioned the drugmaker's pricing power and dealmaking strategy ahead of looming patent expiries.
In the late-stage study, a 1 mg dose of Novo's drug CagriSema was superior to Lilly's tirzepatide at 5 mg for weight loss, the company said on Monday. Lilly's tirzepatide, the active ingredient in its diabetes drug Mounjaro and obesity drug Zepbound, showed a weight loss of 9.1%.
While the low-dose data is encouraging, the findings were less impactful given tirzepatide has already been proven superior to higher doses of Novo's CagriSema in obesity, said BMO analyst Evan Seigerman.
In patients with diabetes, Novo's drug also showed demonstrated non-inferior blood sugar reduction compared to Lilly's tirzepatide.
In another late-stage study, the drug showed a 21% weight loss at a 1.0 mg dose compared to placebo in adults with obesity.
A decision from the U.S. Food and Drug Administration on the company's application for CagriSema for weight management is expected in the fourth quarter.
(Reporting by Sriparna Roy in Bengaluru; Editing by Shinjini Ganguli)
