Zydus Cadila 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 NASH in India, the drug major said on Thursday.
The Ahmedabad-based company said 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 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 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.
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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.
NASH is a large unmet medical need as there is currently no approved drug for the treatment anywhere in the world, a disease that is highly prevalent with 10 per cent to 30 per cent of the global population being affected by it.
The prevalence of NASH in India is estimated to be nearly 25 per cent of the population. NASH ranks as one of the major causes of cirrhosis, behind hepatitis C and alcoholic liver disease.
Liver transplantation is the only option for managing advanced cirrhosis with liver failure.
Shares of Cadila Healthcare, a listed entity of the Zydus group, ended 3.67 per cent up at Rs 265.40 apiece on the BSE.