Drugs maker Zydus Cadila on Thursday said it has received approval from the Drug Controller General of India (DCGI) for its new drug application for Saroglitazar to treat a particular condition of liver, commonly known as NASHin India.
The Ahmedabad-based company said the approved product is the first ever drugany where in the world for treatment of Non-Cirrhotic Non-Alcoholic Steato Hepatitis(NASH) which is a progressive disease of the liver.
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, “Weare 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 patientsin 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.