European Medicines Agency grants Orphan Drug Designation to Zydus Cadila's Saroglitazar Mg

Drug firm Zydus Cadila on Wednesday said the European Medicines Agency has granted 'Orphan Drug Designation' (ODD) to Saroglitazar Mg, used in the treatment of liver disease.

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.

''European Medicines Agency (EMA) has granted 'Orphan Drug Designation' (ODD) to Saroglitazar Mg for the treatment of patients with Primary Biliary Cholangitis (PBC),'' Zydus Cadila said in a statement.

PBC is a liver disease, caused due to the progressive destruction of the bile ducts in the liver which leads to reduction of bile flow.

Earlier this year, the US's health regulator USFDA had granted 'Orphan Drug Designation' and 'Fast Track Designation' to Saroglitazar Mg for PBC.

Zydus Cadila said the global market for PBC treatment is expected to grow at a Compound annual growth rate (CAGR) of 36.3 percent from 2018 – 2026 and is expected to reach USD 10.8 billion by 2026, as per Coherent market insights.

Pankaj R Patel, Chairman, Zydus Group said Primary Biliary Cholangitis is a serious health condition and the company is committed in its clinical development efforts to improve the quality of life of patients suffering from PBC with safe and efficacious treatment.