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VisitFDA approval of semaglutide for liver disease by end of 2025
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FDA official announcements and press releases
Novo Nordisk's Semaglutide Shows Promise in 72-Week Phase 3 Liver Disease Trial with MASH Resolution
Nov 1, 2024, 12:17 PM
Novo Nordisk's semaglutide 2.4 mg has demonstrated significant improvements in liver fibrosis and MASH resolution in its phase 3 ESSENCE trial. The trial, which included 1,200 adults, showed that after 72 weeks, 37% of patients treated with semaglutide experienced fibrosis improvement compared to 22.5% on placebo. Additionally, 62.9% of patients achieved MASH resolution, compared to 34.1% on placebo. The drug also showed a positive safety profile. Novo Nordisk plans to file for regulatory approvals in the US and EU in the first half of 2025. Detailed results from the ESSENCE trial will be presented at an upcoming scientific conference.
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