WASHINGTON (dpa-AFX) - Inovio (INO) said that the European Commission granted orphan drug designation for INO-3107, the company's product candidate for the treatment of Recurrent Respiratory Papillomatosis or RRP.
INO-3107 is an investigational DNA medicine candidate designed to elicit a targeted T cell response against HPV-6 and HPV-11, the HPV types that cause RRP and other HPV-related diseases.
Inovio previously announced that the European Committee for Orphan Medicinal Products (COMP) had provided a positive opinion on Inovio's application for orphan drug designation in the European Union for INO-3107. The adoption of the decision by the EC formalizes INO-3107 as a designated orphan drug in the EU.
INO-3107 received orphan drug designation from the U.S. Food and Drug Administration in July 2020, making it the first RRP product candidate to receive designations from both U.S. and EU regulatory bodies.
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