USFDA grants orphan drug designation to Zydus Cadila's Saroglitazar Mg

Zydus Cadila on Thursday said the US health regulator has granted orphan drug designation (ODD) to its Saroglitazar Mg used for the treatment of patients with Primary Biliary Cholangitis (PBC), a liver disease.

The United States Food and Drug Administration (USFDA) has granted ODD to Saroglitazar Mg, Cadila Healthcare said in a regulatory filing.

Zydus Cadila, which is a part of Cadila Group, said 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 USFDA approval.

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 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 a safe and efficacious treatment.”