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.
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.
