Zydus’ Saroglitazar Receives DCGI’s Approval as the World’s First Therapy for Non-Cirrhotic NASH in India

Shots:

• The approval is based on P-III EVIDENCES II study assessing saroglitazar (4mg) vs PBO in patients with NASH. The study resulted in meeting its 1EPs & 2EPs and demonstrated improvement of NASH using liver biopsy @52wks. and a reduction in liver fat, liver enzymes and disease activity
• In P-II EVIDENCES I study, saroglitazar resulted in improvement in liver enzyme in patients with NAFLD while the EVIDENCES IV study assessing saroglitazar in patients with NASH in the US that resulted in meeting its 1EPs & 2EPs
• Saroglitazar is a dual PPAR agonist, launched in India in Sept’2013 for diabetic dyslipidemia and hypertriglyceridemia in patients with T2D not controlled by statins alone

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