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Zydus Cadila Strides Ahead With NASH Filing In India

API Manufacturing Unit In Dabhasa Receives NAI

 
• By Vibha Ravi

Cadila has filed for approval of saroglitazar for NASH in India. The drug, which could emerge as the first medicine for the indication if approved, is already being used by a million Indian patients for diabetic dyslipidemia and hypertriglyceridemia.  

Jumping
Cadila In A NASH Sprint • Source: Shutterstock

Cadila Healthcare Ltd., part of the Zydus Cadilagroup, has sought regulatory approval in India for saroglitazar magnesium to treat non-alcoholic steatohepatitis (NASH). Cadila said that the novel PPARα/γ agonist has shown a favorable effect on all components of NASH including steatosis, ballooning, inflammation and fibrosis in NASH animal models.

A Phase III liver biopsy-driven trial of saroglitazar 4 mg versus placebo in NASH patients at the end of 52...

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