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Jump to Key Points Oct 20 (Reuters) - Novo Nordisk said on Tuesday its next-generation experimental drug, CagriSema, showed 25% weight loss on average in women with obesity or overweight, according to data analyzed after the completion of a late-stage study.
CagriSema, viewed as a successor to the Danish drugmaker's blockbuster weight-loss drug Wegovy, could help Novo claw back ground lost to rival Eli Lilly in the fast-growing weight-loss market. Wegovy faces patent expiries after 2030.
Novo said a 2.4 milligram dose of CagriSema was associated with an average weight loss of 25% after 68 weeks in 2,309 women enrolled in a late-stage study called REDEFINE 1, compared with 3% weight loss in women on placebo. In the full trial of more than 3,400 adults, CagriSema had led to 22.7% weight loss, below the 25% Novo had targeted.
The data on women participants was presented at the annual meeting of The Menopause Society in San Diego.
- CagriSema 2.4 mg: 25% mean wt loss at 68 wks in women.
- Placebo women: 3% mean wt loss over 68 wks.
- Full REDEFINE 1 trial: 22.7% wt loss; below 25% target.
- Menopause-stage analysis: pre 26.7%, peri 24.8%, post 23.1%.
- FDA weight-management decision expected Q4 this year.
CagriSema is a weekly injection combining cagrilintide, which mimics pancreatic hormone amylin, and semaglutide, the active ingredient in Wegovy.
In a separate post hoc analysis, 1,902 overweight or obese women who received CagriSema 2.4 mg or placebo were evaluated by menopausal stage, Novo said.
CagriSema was associated with clinically meaningful weight loss across all menopause stages by week 68, with an average weight loss of 26.7% in premenopausal women, 24.8% in perimenopausal women and 23.1% in postmenopausal women.
"Many women with obesity or overweight experience weight gain as they move through menopause, and it is important to explore investigational products such as CagriSema across the reproductive lifespan,” said Michelle Skinner Moore, vice president, medical affairs at Novo.
Post hoc analyses are conducted after trials meet their primary goals. Novo said they were hypothesis-generating and required further study.
A US FDA decision on the approval of CagriSema for weight management is expected in the fourth quarter of this year.
(Reporting by Sneha S K in Bengaluru; Editing by Jonathan Ananda)
