The Drug Controller General of India (DCGI) has granted approval for saroglitazar to treat non-cirrhotic non-alcoholic steato hepatitis (NASH) in India, announced Zydus Cadila.
NASH is a progressive disease affecting 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.
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.”
The company had launched saroglitazar under the trade name Lipaglyn in the country in 2013 for treatment of diabetic dyslipidemia and hypertriglyceridemia in patients with Type-2 diabetes not controlled by statins alone.
In January 2020, saroglitazar had scored approval for the treatment of Type-2 diabetes mellitus.
The drug has been found to reduce liver fat, liver enzymes and disease activity during trials in India, the company said in a statement, adding it has also met primary and secondary endpoints during trials in the US.