The U.S. Food and Drug Administration granted accelerated approval for Novo Nordisk’s blockbuster weight-loss drug Wegovy to treat metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate-to-advanced liver fibrosis who do not yet have cirrhosis. The decision, announced late Friday, makes Wegovy the first GLP-1 agonist cleared for the progressive liver disease, which Novo estimates affects about 22 million Americans. Regulators based the clearance on results from the Phase 3 ESSENCE study, where 37 percent of patients receiving Wegovy showed an improvement in liver fibrosis without worsening steatohepatitis after 72 weeks, compared with 22 percent for placebo. Sixty-three percent achieved resolution of steatohepatitis without fibrosis progression versus 34 percent for placebo, supporting the drug’s benefit when used alongside diet and exercise. Analysts view the new label as opening a market that could reach roughly US$30 billion, giving Novo Nordisk a head-start over rival Eli Lilly, whose tirzepatide-based Zepbound is still in mid-stage MASH trials. The Danish drugmaker has also sought approvals in Europe and Japan. Investors welcomed the news. Novo Nordisk shares rose as much as 5 percent in Copenhagen trading on Monday and gained about 7 percent in U.S. pre-market dealings, partially reversing a slump that had wiped more than a third of the company’s value in recent weeks. Eli Lilly slipped roughly 1 percent on the prospect of intensified competition in liver care.
ノボの肥満症薬、FDAが脂肪肝炎向け治療で承認 株価一時8%高 https://t.co/zHuSCwxpvh
Shares in Novo Nordisk rise after Wegovy gets US nod for liver disease treatment https://t.co/KGKuG5SqY2 https://t.co/KGKuG5SqY2
Shares in Novo Nordisk rose as much as 5% at opening after the US FDA granted accelerated approval for Wegovy to treat metabolic dysfunction-associated steatohepatitis, or MASH https://t.co/z5jaw7ZxKB https://t.co/vTTBBPFnGH