INOVIO Announces Orphan Drug Designation for INO-3107 for the Treatment of Recurrent Respiratory Papillomatosis
INOVIO, a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the European Commission (EC) has granted orphan drug designation for INO-3107, the company’s product candidate for the treatment of Recurrent Respiratory Papillomatosis (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 (EU) for INO-3107. The adoption of this 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 (FDA) in July 2020, making it the first RRP product candidate to receive designations from both U.S. and EU regulatory bodies.
“By granting orphan drug designation, U.S. and EU regulators are acknowledging the high unmet medical need of those suffering from this debilitating disease,” said INOVIO Senior Vice President of Regulatory Affairs, Dr. Cheryl Elder, “This is yet another important step forward for our development process and for the RRP patients around the world who could benefit from a potentially game-changing therapy.”
Orphan drug designation is granted for the treatment, prevention, or diagnosis of diseases that are life-threatening or chronically debilitating and affect no more than five in 10,000 people across the European Union (EU). Medicines that are granted orphan drug designation by the EC qualify for financial and regulatory incentives including protocol assistance at reduced charges, access to centralized marketing authorization, and up to 10 years of market exclusivity in the EU after product approval.
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