Ahmedabad, Mar 5 : Leading Pharma company Zydus Cadila on Thursday announced that the Drug Controller General of India (DCGI) has approved its New Drug Application (NDA) for Saroglitazar for the treatment of Non-Cirrhotic Non-Alcoholic SteatoHepatitis (NASH) in India. Addressing a press conference here, Chairman, Zydus Group Pankaj Patel said that NASH is a progressive disease of the liver, which starts with fat accumulation in the liver known as NonAlcoholic Fatty Liver Disease (NAFLD).
This condition could progress to cirrhosis and liver failure. It is a large unmet medical need as there is currently no approved drug for the treatment of NASH anywhere in the world, a disease that is highly prevalent with 10 pc to 30 pc of the global population being affected by it. It would be launched in India soon but would take some time for global launch,' he added.
Mr Patel said Saroglitazar was launched 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.(UNI)