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Zydus receives Orpan Drug status for Saroglitazar Mg in Europe

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Zydus today 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.

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First Published: Jul 21 2021 | 11:32 AM IST

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