The national drugs regulator has approved Novo Nordisk’s weight-loss drug, Wegovy, for use in adults living with fatty liver disease, the company announced on Friday.
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“The Central Drugs Standard Control Organization (CDSCO) has approved a new indication for Wegovy (semaglutide injection 2.4 mg), making it the first and only GLP-1 RA to be approved both globally and in India for the treatment of noncirrhotic metabolic dysfunction associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis along with a reduced calorie diet and increased physical activity,” said Denmark based global health care company in a statement.
MASH is a liver disease that develops due to excess fat build-up in the liver, causing chronic inflammation and liver damage.
“The burden of MASH continues to rise in India, but treatment options are still severely limited. People with MASH face a higher risk of serious liver complications and heart-related disease. That is why we need treatment options that can address these connected health risks. This approval is an important milestone, giving doctors and patients a new option for people at risk of MASH while also helping to address obesity and related heart and metabolic diseases,” said Vikrant Shrotriya, managing director, Novo Nordisk India, in a statement.
Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).
It is also indicated for chronic weight management in adolescents ≥12 years with obesity and body weight above 60 kg.
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According to estimates, two in three Indians have fatty liver disease. It is a silent disease and people often do not have symptoms until the disease has progressed to an advanced stage. The condition can be life-threatening if not properly managed.
According to the company, in its ESSENCE clinical trial, 63% of patients (2 out of 3) on Wegovy saw resolution of steatohepatitis with 37% (1 out of 3) seeing reduction in liver fibrosis1. Nearly 33% of patients (1 out of 3) treated with Wegovy also achieved both resolution of steatohepatitis as well as improvement in liver fibrosis. In addition, the liver benefits appear not to be solely explained by weight loss, suggesting a broader potential impact on liver health.
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