PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) announced that the European Committee for Orphan Medicinal Products (COMP) recently provided a positive opinion on INOVIO’s application for orphan drug designation in the European Union (EU) for INO-3107.
INO-3107 is the company’s product candidate that may contribute to the treatment of Recurrent Respiratory Papillomatosis (RRP). The opinion is now with the European Commission, which will provide a final decision on the application within 30 days.
Orphan designation is for medicines in development for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious. The Orphan Medicinal Products Regulation (Regulation (EC) No 141/2000) defines an orphan medicinal product as one intended for diseases affecting fewer than 5 in 10,000 people across the EU.