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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