Novo Nordisk’s Wegovy gets FDA accelerated approval for liver disease MASH

DENMARK—Novo Nordisk has revealed that the US Food and Drug Administration (FDA) has granted accelerated approval for a new use of its medication Wegovy® (semaglutide 2.4mg).

This approval is based on a supplemental New Drug Application (sNDA) and allows the prescription of Wegovy® for adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) who also have moderate to advanced liver fibrosis, specifically stages F2 to F3.

 Importantly, physicians will prescribe Wegovy® alongside a reduced-calorie diet and increased physical activity.

This regulatory decision follows the positive results of the ESSENCE trial, particularly part one, which demonstrated that Wegovy® produced meaningful clinical benefits for patients with MASH.

In the trial, researchers observed that, by week 72, 36.8% of patients treated with Wegovy® experienced improvement in liver fibrosis without worsening of steatohepatitis.

For comparison, only 22.4% of those taking a placebo achieved the same benefit.

Furthermore, 62.9% of participants taking Wegovy® achieved resolution of steatohepatitis without any new or worsening liver fibrosis, whereas just 34.3% of the placebo group saw similar improvements.

The results proved statistically significant, showing that Wegovy® offers substantial advantages for this patient population.

Martin Holst Lange, the executive vice president, chief scientific officer, and head of Research and Development at Novo Nordisk, commented that this approval marks a major milestone for people living with MASH.

He emphasized that Wegovy® is now the first and only GLP-1 treatment approved for MASH.

This builds on its proven effectiveness in supporting weight loss and enhancing cardiovascular health, backed by a substantial body of evidence for its active ingredient, semaglutide.

This sets Wegovy® apart from other treatments and underscores the company’s dedication to addressing major health concerns.

Lange also drew attention to the fact that MASH represents a severe and growing health burden.

He noted that globally, one in three people with overweight or obesity lives with this condition.

Within the United States, experts estimate that roughly 22 million individuals are currently affected by MASH.

With this latest FDA approval, Novo Nordisk is providing people with MASH a new and much-needed therapy that not only halts disease progression but also helps reverse the damage already inflicted on the liver.

Effective immediately, Wegovy® is available in the United States for the treatment of MASH.

 This advancement offers hope to millions, marking a crucial step forward in the management and potential reversal of this challenging and widespread liver disease.

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