Emcitate® receives EU orphan drug designation

RTT announced today that its lead product candidate Emcitate™ has received an orphan drug designation by the European Commission. The EU orphan drug legislation was adopted in 2000 and provides incentives for the development of pharmaceuticals with an anticipated significant benefit in the treatment of rare disorders with an unmet medical need. The designation allows for a number of incentives including free advice and fee waivers during the development phase. Following approval, products with orphan drug designation receive ten years of market exclusivity, during which no similar medicines developed for the same indication can be marketed in the community.

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