Zydus Cadila files for Indian approval of saroglitazar for the treatment of NASH

5 December 2019

Zydus Cadila, part of the Cadila Healthcare (BOM: 532321) has filed the New Drug Application (NDA) for saroglitazar magnesium in the treatment of non-alcoholic steatohepatitis (NASH) with the Drug Controller General of India (DCGI).

Assuming the drug gains approval, it could become the first medicines indicated for the treatment of NASH, the company noted.

NASH is a progressive disease of the liver and a significant unmet medical need. There are currently no treatments available for the treatment of NASH. Starting with fat accumulation in liver, this condition can progress to cirrhosis and liver failure. 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.

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