Non-Cirrhotic Non-Alcoholic SteatoHepatitis (NASH) is a progressive disease of the liver, which starts with fat accumulation in the liver known as non-alcoholic fatty liver disease. This condition could progress to cirrhosis and liver failure, the company said in a statement.
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 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.
The drug has been found to reduce significantly liver fat, liver enzymes and disease activity during trials in India, the company said, adding it has also met primary and secondary endpoints during trials in the US. RKL BAL