Sumitomo Pharma recently announced that Novo Nordisk Pharma has received a partial change approval of the manufacturing and Marketing Authorisation (MA) from the Ministry of Health, Labour and Welfare (MHLW) in Japan for Wegovy Subcutaneous Injection SD and MD, a once-weekly GLP-1 receptor agonist co-promoted with Sumitomo Pharma in Japan. This approval covers an additional indication for metabolic dysfunction-associated steatohepatitis (MASH) without cirrhosis in patients with moderate to advanced fibrosis.

With this approval, the product becomes the first approved treatment for MASH in Japan. Building on the collaborative relationship established with Novo Nordisk Pharma through promotional activities for obesity disease, the company will continue to work closely with Novo Nordisk Pharma to provide information to healthcare professionals regarding MASH.

This approval is based on part 1 of the phase 3 ESSENCE study, which enrolled adult patients with MASH and moderate to advanced fibrosis. The product (semaglutide 2.4 mg) demonstrated superiority to placebo with statistically significant results compared to placebo in both improvement in liver fibrosis without worsening of MASH and resolution of MASH without worsening of liver fibrosis. In part 1 of the ESSENCE study, at week 72, improvement in liver fibrosis without worsening of MASH was observed in 36.8 percent of patients in the product (semaglutide 2.4 mg) group compared with 22.4 percent in the placebo group. In addition, resolution of MASH without worsening of liver fibrosis was observed in 62.9 percent of patients in the product (semaglutide 2.4 mg) group compared with 34.3 percent in the placebo group. The safety profile was consistent with previous data, and no new safety concerns were identified.

MASH is a progressive disease that often presents with few symptoms in its early stages but may lead to irreversible liver fibrosis, liver failure, and liver cancer over time, posing significant health risks to patients. This serious liver disease is also frequently associated with other metabolic conditions such as obesity and Type 2 Diabetes (T2D).

The company is also jointly engaged with Novo Nordisk Pharma in providing information to healthcare professionals regarding Ozempic Subcutaneous Injection 2 mg, a once-weekly GLP-1 receptor agonist indicated for the treatment of T2D. By leveraging the expertise and networks of both companies, the company will continue to work closely with Novo Nordisk Pharma to provide information so that more patients can benefit from these treatments.