Zydus, a leading discovery-based global pharmaceutical company, has announced that European Medicines Agency (EMA) has granted ‘Orphan Drug Designation’ (ODD) to Saroglitazar Mg for the treatment of patients with Primary Biliary Cholangitis (PBC).

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 5 people 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 centralized marketing authorization procedure valid in all EU Member States, and a 10-year period of market exclusivity if the treatment eventually is approved.

Earlier, the USFDA has granted ‘Orphan Drug Designation’ and ‘Fast Track Designation’ to Saroglitazar Mg for PBC.

The global market for PBC treatment is expected to grow at a CAGR of 36.3% from 2018-2026 and is expected to reach US $10.8 billion by 2026 as per Coherent market insights.

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.”

Primary Biliary Cholangitis (PBC) is a liver disease, caused due to progressive destruction of the bile ducts in the liver which leads to reduction of bile flow – a condition referred to as cholestasis.