Orphan Drug Designation Grants European Medicines Agency (EMA) For Saroglitazar Mg

Release Date: 13-Sep-2021

(Zydus Cadila), a healthcare Ltd has received Orphan Drug Designation from the EU regulator, European Medicines Agency (EMA), for Saroglitazar Mg to treat Primary Biliary Cholangitis (PBC). PBC is a liver disease, caused due to progressive destruction of the bile ducts in the liver that leads to reduction of bile flow andndash; a condition referred to as cholestasis.


Saroglitazar Mg is an effective and selective peroxisome proliferator-activated receptor alpha and gamma dual agonist. The results of Phase 2, prospective multicentre randomised double-blind, placebo-controlled study to value the tolerability, safety and efficacy of Saroglitazar Mg in patients with PCB was presented earlier at the annual meeting of the American Association for the Study of Liver Diseases.


It is given to investigational therapies that have the power to treat rare and life-threatening diseases that affect less than five in 10,000 patients in the European Union. It provides some benefits to companies, like clinical protocol advice, fee reductions, and ten years of protection from competition following regulatory approval.

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