GlycoMimetics, Inc. Announces European Medicines Agency’s Granting of Orphan Drug Status in European Union for GMI-1070 in Sickle Cell Disease
9/13/2013 9:43:11 AM
GAITHERSBURG, Md.--(BUSINESS WIRE)--GlycoMimetics, Inc. announced today that the European Medicines Agency (EMA) has granted orphan drug designation for GMI-1070 (rivipansel sodium) for the treatment of vaso-occlusive crisis (VOC) in patients with sickle cell disease. Orphan drug designation in the European Union (EU) is given to products that are designed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious. A disease is defined as rare in the EU if it affects fewer than five in 10,000 people. Granting of orphan drug designation in the EU provides companies with development and commercial incentives, including a 10-year period of market exclusivity, access to a centralized review process, protocol assistance and scientific advice during product development, waiving or reduction of certain fees, and eligibility for grants and R&D support initiatives.
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