EMA grants Orphan Drug Designation to Saroglitazar Mg for treating patients with PBC

Zydus announced that the European Medicines Agency (EMA) has granted ‘Orphan Drug Designation’ (ODD) to Saroglitazar Mg for the treatment of patients with Primary Biliary Cholangitis (PBC).

In a company release, Zydus said that the Orphan drug status in Europe is given to medicines with the potential to be safe and effective treatments for rare, life-threatening, or chronically debilitating conditions affecting no more than five in 10,000 people. It provides companies with a range of incentives, including assistance with trial protocols, reduced regulatory fees, differentiated evaluation procedures for Health Technology Assessments in certain countries, access to a centralised marketing authorisation procedure valid in all EU Member States, and a 10-year period of market exclusivity if the treatment eventually is approved.

It further said that Saroglitazar Mg is a potent and selective peroxisome proliferator-activated receptor alpha and gamma dual agonist. Results of PHASE 2, prospective multicentre randomised double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of Saroglitazar Mg in patients with PBC (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.

Speaking on the development, Pankaj R Patel, Chairman, Zydus Group, said, “We are pleased that the EMA has granted an Orphan Drug Designation to Saroglitazar Mg for the treatment of Primary Biliary Cholangitis (PBC). This is a serious health condition and 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.”