Zydus’s Saroglitazar Mg Granted Orphan Drug Designation By USFDA

Zydus has announced that the United States Food and Drug Administration (USFDA) granted ‘Orphan Drug Designation’ (ODD) to Saroglitazar Mg. The drug is indicated for the treatment of patients with Primary Biliary Cholangitis (PBC). Saroglitazar Mg is a powerful and selective peroxisome proliferator-activated receptor alpha and gamma dual agonist. Primary Biliary Cholangitis is a chronic condition in which the bile ducts are slowly destroyed.

Upon FDA approval, orphan drug designation provides the eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity. In December 2020, USFDA granted ‘Fast Track Designation’ to Saroglitazar Mg for PBC.

A statement from the company informed that, “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.”

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.”

Source-Medindia