Zydus receives USFDA 'Orphan Drug Designation' for Saroglitazar Mg

Zydus 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) [ClinicalTrials.gov Identifier: NCT03112681]. The treatment options are still evolving for PBC and Saroglitazar holds immense potential based on its safety and efficacy profile so far. The global market for PBC treatment is expected to grow at a CAGR of 36.3% from 2018 2026 and is expected to reach USD 10.8 bn by 2026 as per Coherent market insights.

 

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