India, June 19 -- 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 o...