Novo Nordisk's Wegovy gets accelerated U.S. approval for liver disease
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 one 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.
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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 one 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.
