The European Medicines Agency’s (EMEA) Orphan Medicinal Product Designation is designed to promote the development of drugs which may provide benefit to patients suffering from rare diseases identified as life-threatening or very serious conditions.
Under EMEA guidelines, Orphan Medicinal Product Designation provides 10 years of potential market exclusivity if the product candidate is approved for marketing in the European Union. Orphan status also permits EMEA assistance in optimizing the candidate’s clinical development through participation in designing the clinical protocol and preparing the marketing application.
Thierry Darcis, ViroPharma’s vice president and general manager, Europe, said: “This designation from the EMEA adds additional momentum as we continue to develop Camvia for transplant-related cytomegalovirus disease. We commend the European Commission for providing incentives for the development of drugs for rare and life threatening diseases.”