Indian regulators approve first drug for patients with NASH

pharmafile | March 6, 2020 | News story | Medical Communications FDA Approval, India, Indian Pharma, drug approval 

The Drug Controller General of India (DCGI) has approved the marketing application for Zydus Cadila’s saroglitazar to treat patients with non-cirrhoitc non-alcoholic steatohepatitis (NASH).

According to the company, the drug, which is already approved for type 2 diabetes, dyslipidaemia and hypertriglyceridaemia, becomes the first drug anywhere in the world to be approved as a treatment for non-cirrhotic NASH.

It was approved based on a Phase III trial comparing saroglitazar versus a placebo in terms of histological improvement of NASH using liver biopsy at the end of a year. In Indian patients it met its primary and secondary endpoints, demonstrating a significant reduction in liver fat, liver enzymes and disease activity.

In a previous US Phase trial II study, saroglitazar was associated with improvement in liver enzymes and lipids in patients with non-alcoholic fatty liver disease (NAFLD). Zydus Cadila is also conducting the EVIDENCES III and EVIDENCES V trials, where the first of these will be testing saroglitazar versus placebo among NAFLD patients in terms of change in liver fat content as measured by magnetic resonance imaging.

The EVIDENCE V trial will evaluate change in liver fat in NASH patients over a period of 18 months via MRI-derived proton density-fat fraction, as well as liver biopsy-driven endpoints. 

Sharvil Patel, Managing Director at Zydus Cadila, stated he is looking to expand its share of this market, saying: “Globally, the market potential for NASH treatment is estimated to be around $35 billion to $40 billion…we are looking to have a piece of that pie.”

Conor Kavanagh

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