Zydus Cadila gets USFDA Orphan Drug Designation for Saroglitazar Mg to treat PBC
Saroglitazar Mg is a potent and selective peroxisome proliferator-activated receptor alpha and gamma dual agonist.;
Ahmedabad: Drug major, Zydus Cadila, has recently announced that United States Food and Drug Administration (USFDA) has granted 'Orphan Drug Designation' (ODD) to Saroglitazar Mg for the treatment of patients with Primary Biliary Cholangitis (PBC).
Orphan drug designation provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval. This follows the grant of 'Fast Track Designation' by the USFDA to Saroglitazar Mg for PBC in December 2020.
Saroglitazar Mg is a potent and selective peroxisome proliferator-activated receptor alpha and gamma dual agonist.
Results of PHASE 2, prospective multicentre randomized double-blind, placebo controlled study to evaluate the safety, tolerability and efficacy of Saroglitazar Mg in patients with PRIMARY BILIARY CHOLANGITIS (EPICS) was presented earlier at the Liver Meeting 2020, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).
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