(Reuters) -Novo Nordisk said on Friday the U.S. Food and Drug Administration had granted accelerated approval for its weight-loss drug Wegovy to treat a serious liver condition known as metabolic dysfunction-associated steatohepatitis.
This makes Wegovy the first GLP-1 class therapy cleared for MASH, a progressive liver condition that affects around 5% of adults in the U.S., according to the American Liver Foundation.
The FDA’s decision was based on part 1 of a two-part study that showed Wegovy had helped improve the organ’s condition in more patients with MASH and liver scarring, compared to a placebo.
At 72 weeks, nearly 37% of patients on the Danish drugmaker’s treatment showed an improvement in liver fibrosis, compared to 22.4% on the placebo.
Nearly 63% of those on Wegovy had their liver inflammation resolved, versus 34.3% for the placebo. No worsening of the disease was seen in these patients.
Novo Nordisk said the drug is now available in the U.S. for adults with MASH and moderate to advanced liver scarring, and is to be used alongside diet and exercise.
The only available FDA-approved treatment for MASH is Madrigal Pharmaceuticals’ Rezdiffra.
Rival Eli Lilly’s tirzepatide – the active ingredient in its popular diabetes drug Mounjaro and weight-loss treatment Zepbound – previously helped up to 74% of patients achieve absence of MASH with no worsening of scarring in a mid-stage trial.
Based on results from part 1 of the trial, Novo has applied for approval in Europe and Japan earlier this year.
Further results from part 2 of the ongoing trial are expected in 2029.
Accelerated approvals allow the agency to move therapies that target serious and life-threatening conditions to the market more quickly.
However, such approvals have been criticized because some drugs have later been proven to be ineffective.
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Sriraj Kalluvila)
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