Sumitomo Pharma Co., Ltd. (4506.T) announced on Friday that Japan has cleared Wegovy Subcutaneous Injection, which it co-promotes with Novo Nordisk B A/S (NVO), to treat metabolic dysfunction-associated steatohepatitis or MASH, marking the first approval for the liver disease in the country.
The approval covers an additional indication for MASH without cirrhosis in patients with moderate to advanced liver fibrosis.
The authorization was based on Part 1 of the Phase 3 ESSENCE study of adults with MASH and stage 2 or stage 3 fibrosis. In the study, 36.8 percent of patients receiving Wegovy 2.4 mg showed improvement in liver fibrosis without worsening of MASH at week 72, compared with 22.4 percent for placebo.
Resolution of MASH without worsening of liver fibrosis occurred in 62.9 percent of patients on Wegovy versus 34.3 percent for placebo. No new safety concerns were identified, and the safety profile was consistent with previous data, the company said in a statement.
MASH is a progressive liver disease linked to obesity and type 2 diabetes that can lead to liver fibrosis, liver failure and liver cancer. It often shows few symptoms in early stages.
Wegovy, known generically as semaglutide, is co-promoted in Japan by Sumitomo Pharma and Novo Nordisk Pharma. It is a once-weekly GLP-1 receptor agonist already approved in Japan for obesity.
Novo Nordisk and Sumitomo Pharma also co-promote Ozempic Subcutaneous Injection, a GLP-1 drug for type 2 diabetes, in Japan.
On the NYSE, shares of Novo Nordisk closed Thursday's regular trading 0.76 percent lower, at $43.19.
On the Tokyo stock exchange, shares of Sumitomo Pharma closed Friday's trading 3.64 percent lower at 1,469.50 Japanese Yen.
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