Aug 15 (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.
The decision 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 approval is for use alongside a reduced-calorie diet and
increased physical activity.
The FDA's approval was based on part 1 of a two-part study
that showed Wegovy helped more patients with MASH and liver
scarring improve the organ's condition, compared to a placebo.
At 72 weeks, nearly 37% of patients on Wegovy saw an
improvement in liver fibrosis, compared to 22.4% on placebo.
Nearly 63% of those on Wegovy had their liver inflammation
resolved, versus 34.3% for placebo. No worsening of the disease
was seen in these patients.
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)