Positive EU opinion for orphan drug exclusivity for Raptor's Procysbi
US drugmaker Raptor Pharmaceuticals (Nasdaq: RPTP) has received a positive opinion from the European Union Committee for Orphan Medical Products (COMP) recommending orphan drug exclusivity for Procysbi (cysteamine bitartrate).
The gastro-resistant hard capsules are intended for the management of nephropathic cystinosis, a rare genetic condition, in children and adults. Final adoption of the opinions on drug approval and orphan exclusivity are expected from the European Commission in the coming months.
Christopher Starr, Raptor's chief executive, said: "The positive opinion from COMP is another welcome milestone for Raptor and Procysbi as we seek to bring this important new product to European patients who suffer from cystinosis. Orphan designation will provide the company with 10 years of marketing exclusivity in the European Union alongside our IP estate."
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