The Ahmedabad-based drug major Zydus Cadila has said that it received approval from the Drug Controller General of India (DCGI) for its new drug application for Saroglitazar.
The drug is used to treat a particular condition of the liver, commonly known as NASH in India.
The approved product is the first ever drug anywhere in the world for treatment of Non-Cirrhotic Non-Alcoholic SteatoHepatitis (NASH) which is a progressive disease of the liver, the company said.
The condition starts with fat accumulation in the liver known as non-alcoholic fatty liver disease and progress to cirrhosis and liver failure.
Commenting on the approval, Zydus Group Chairman Pankaj Patel said, “We are happy that our efforts to discover and develop a novel drug for patients living with NASH, an unmet healthcare need globally, have been successful. Saroglitazar will provide hope and new lease of life for millions of patients in India suffering from NASH”.
The company had launched Saroglitazar in India in September 2013 for the treatment of diabetic dyslipidemia and hypertriglyceridemia in patients with Type-2 diabetes not controlled by statins alone.
In January this year, Saroglitazar received an approval for the treatment of Type-2 diabetes Mellitus. In the last seven years, over a million patients have benefitted from this drug, Zydua Cadila said.