European Medicines Agency Grants PRIME and Advanced Therapy Medicinal Product Designations to Janssen ’s RPGR Gene Therapy for X-Linked Retinitis Pigmentosa

RARITAN, NJ, March 2, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Medicines Agency (EMA) has granted both PRIME (PRIority MEdicines) and Advanced Therapy Medicinal Product (ATMP) designations to the company’s adeno-associated virus (AAV)-RPGR gene therapy product for the treatment of inherited retinal disease X-linked retinitis pigmentosa (XLRP). PRIME is awarded to increase interactions, optimize development plans and accelerate innovative treatments where there is unmet medical need. Similarly, ATMP status is granted to medicines that are based on genes, tissues or cells and can offer groundbreaking opportunities for the treatment of disease. The novel AAV-RPGR asset, which is being jointly developed with MeiraGTx Holdings plc, also received Fast Track designation from the U.S. Food and Drug Administration (FDA) and Orphan designations from the FDA and the EMA. The PRIME designation is based on data from the ongoing Phase 1/2 clinical trial (NCT03252847). For more information, visit: https://clinicaltrials.gov/ct2/show/NCT03252847?term=rpgr&draw=2&rank=1. “The PRIME and ATMP designations for our gene therapy asset are important achievements for Janssen’s growing retinal portfolio and bring us one step closer to delivering a transformational therapy to European patients living with X-linked retinitis pigmentosa,” said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabo...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news