On Saturday, the U.S. Food and Drug Administration (FDA) approved an additional indication for Novo Nordisk A/S’ Wegovy (semaglutide 2.4 mg) based on a supplemental New Drug Application (sNDA) for noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), in combination with a reduced calorie diet and increased physical activity.

The accelerated approval is based on part 1 of the ESSENCE trial, in which Wegovy demonstrated a statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis compared to placebo.

The clinical data from ESSENCE showed that at week 72, 36.8% of people treated with Wegovy achieved improvement in liver fibrosis with no worsening of steatohepatitis compared to 22.4% treated with placebo. 62.9% of people treated with Wegovy achieved resolution of steatohepatitis with no worsening of liver fibrosis compared to 34.3% treated with placebo.

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In part 2, the objective is to demonstrate that treatment with semaglutide 2.4 mg lowers the risk of liver-related clinical events compared to placebo in adults with MASH and moderate to advanced liver fibrosis at 240 weeks. Part 2 of the ESSENCE trial will continue with the expected readout in 2029.

The approval marks a positive development for Novo Nordisk ( NVO ) as the European company faces downward sales for its GLP-1 products due to slower-than-expected penetration of its branded GLP-1 treatments and persistent use of compounded GLP-1 alternatives.

Novo Nordisk ( NVO ) projects 2025 sales growth to be in the range of 8-14% at constant exchange rates, a notable reduction from its earlier forecast of 13-21%.

In May, Health Canada accepted for review, under the Priority Review policy, its supplemental new drug submission (sNDS) for semaglutide 2.4 mg, a once-weekly therapy for MASH.

In March 2024, the FDA approved a label expansion for Wegovy based on a supplemental New Drug Application for reducing risks of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal heart attack (myocardial infarction), or non-fatal stroke in adults with either overweight or obesity and established cardiovascular disease (CVD).

The approval was based on the SELECT cardiovascular outcomes trial, which demonstrated that Wegovy statistically significantly reduced the risk of MACE by 20% compared to placebo when added to standard of care.

The findings from SELECT also showed that risk reductions in MACE were achieved in up to five years.

In addition, the label was updated to include data from SELECT showing a risk reduction in cardiovascular death by 15% and a risk reduction of death from any cause by 19%, compared to placebo.

In March 2024, Madrigal Pharmaceuticals Inc.’s Rezdiffra (resmetirom) became the first FDA-approved treatment for patients with liver scarring due to fatty liver disease.

The FDA granted accelerated approval, and continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.

Price Action: NVO shares climbed 7.14% to $56.15, up $3.74, in after-hours trading on Friday.

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