Medicines that are awarded orphan drug designations in the EU benefit from a number of rewards, including 10 years of market exclusivity and reduced regulatory fees.
EU’s ‘Significant Benefit’ Metric For Orphan Drugs Still A Thorn In Industry’s Side
Ipsen’s Bylvay is one of six medicines that the European Medicines Agency has said should be stripped of their orphan drug designation over the last three years, leading the company to criticize the agency’s approach to “significant benefit” assessments.
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