Zydus Cadila files NDA of Saroglitazar Mg for treatment of NASH with DCGI

05 Dec 2019 Evaluate

Zydus Cadila has filed the NDA of Saroglitazar Mg in Non-alcoholic Steatohepatitis (NASH) with the Drug Controller General of India (DCGI). 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.

The company had also achieved positive results in EVIDENCES II phase 3 biopsy-driven trial of Saroglitazar 4 mg versus placebo in patients with Non-Alcoholic SteatoHepatitis.

Cadila Healthcare is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.


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