Krystal(US:KRYS) Globenewswire·2025-02-28 12:40Core Viewpoint - The European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive recommendation for the approval of VYJUVEK for treating wounds in patients with dystrophic epidermolysis bullosa, with a final decision expected in the second quarter of 2025 [1][2]. Group 1: Product Information - VYJUVEK is a non-invasive, topical gene therapy designed to deliver two copies of the COL7A1 gene directly to DEB wounds, addressing the fundamental disease-causing mechanism [6]. - The therapy promotes durable wound closure and is suitable for patients from birth, with administration options available for trained patients or caregivers at home [1][4]. - VYJUVEK was previously approved in the United States in May 2023 for patients six months of age and older [6][9]. Group 2: Clinical Evidence - The CHMP's positive opinion is based on comprehensive clinical data from the Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, which demonstrated successful COL7A1 gene delivery and durable wound closure [3]. - Long-term safety and efficacy are supported by results from an open-label extension study in the U.S. and real-world experience since the product's U.S. launch [3]. Group 3: Market Strategy - The company plans to launch VYJUVEK in Germany around mid-2025, followed by a launch in France later that year, aiming to maximize patient access [5]. - The approval by the EC would allow the company to market B-VEC under the registered European trademark VYJUVEK across the EU and additional countries [4].