The national drug regulator has approved Novo Nordisk’s weight-loss drug Wegovy for the treatment of adults with fatty liver disease, the company announced Friday.
“The Central Drugs Standards Control Organization (CDSCO) has approved a new indication for Wegovy (semaglutide 2.4 mg injection), making it the first GLP-1 RA approved globally and in India for the treatment of non-cirrhosis associated steatohepatitis (MASH) metabolic dysfunction in adults with moderate to advanced cirrhosis combined with a low-calorie diet and increased physical activity,” the Denmark-based global healthcare company said in a statement.
MASH is a liver disease that develops due to the accumulation of excess fat in the liver, causing chronic inflammation and liver damage.
According to estimates, two out of every three Indians suffer from fatty liver disease. It is a silent disease and people often do not show symptoms until the disease advances to an advanced stage. The condition can be life-threatening if not managed properly.
According to the company, in its ESSENCE clinical trial, 63% of patients (2 of 3) on Wegovy saw resolution of their steatohepatitis, while 37% (1 of 3) saw a reduction in liver fibrosis1. Approximately 33% of patients (1 of 3) treated with Wegovy also achieved resolution of steatohepatitis as well as improvement in liver fibrosis. Additionally, it appears that the liver benefits are not solely explained by weight loss, suggesting a broader potential impact on liver health.
Read also:India gets Novo Nordisk’s Oakley insulin injection once a week for adults with diabetes
“The burden of MASH continues to rise in India, but treatment options are still very limited. People with MASH face a greater risk of developing serious liver complications and heart-related diseases. That’s why we need treatment options that can address these associated 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 cardio-metabolic diseases,” Vikrant Shrotriya, managing director, Novo Nordisk India, said in a statement.
Wegovy is indicated as an adjunct to a low-calorie diet and increased physical activity to manage chronic weight in adults with an initial body mass index (BMI) of 30 kg/m2 or more (obesity) or 27 kg/m2 or more (overweight) in the presence of at least one weight-related comorbid condition (such as hypertension, type 2 diabetes, or dyslipidemia).
It is also indicated for chronic weight control in adolescents over 12 years of age who are obese and have a body weight above 60 kg.
