US FDA grants Orphan Drug Designation to Zydus’ Saroglitazar for primary biliary cholangitis treatment

Saroglitazar Mg is a potent and selective peroxisome proliferator-activated receptor alpha and gamma dual agonist. Zydus announced that the 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). 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 per cent from 2018 — 2026 and is expected to reach $10.8 billion by 2026, as per Coherent market insights,” informed a statement from the company.

Speaking on the development, Pankaj R Patel, Chairman, Zydus Group said, “We are pleased that the USFDA has granted an Orphan Drug Designation apart from the earlier Fast Track Designation to Saroglitazar Mg for the treatment of Primary Biliary Cholangitis (PBC). This underlines the urgent need to address this serious health condition which is an unmet medical need. We are committed in our clinical development efforts to improve the quality of life of patients suffering from PBC with safe and efficacious treatment.”