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ZEVASKYN Approval Positions Abeona as Emerging Player in Dystrophic Epidermolysis Bullosa Market | DelveInsight
Approximately a year after the FDA rejected its previous approval submission, Abeona announced that the agency had approved ZEVASKYN, its autologous cell-based gene therapy for both adult and pediatric patients with RDEB. This approval marks Abeona's entry into the commercial gene therapy market for dystrophic epidermolysis bullosa.
LAS VEGAS, May 22, 2025 /PRNewswire/ -- Dystrophic epidermolysis bullosa (DEB) is one of the main subtypes of epidermolysis bullosa, a group of genetic skin disorders characterized by varying degrees of fragility in the skin and mucous membranes. This fragility occurs due to the absence, deficiency, or malfunction of proteins critical to maintaining skin structure. In the 7MM, approximately 6,500 diagnosed prevalent cases of DEB were recorded in 2023, with the United States accounting for about 50% of these cases.
Currently, there is no cure for DEB. Management is primarily supportive, focusing on wound care, controlling pain and itching, preventing infections, providing nutritional assistance, and addressing complications that may arise.
Learn more about the DEB therapeutic market @ Dystrophic Epidermolysis Bullosa Treatment Market
As of now, only four therapies, namely FILSUVEZ (Chiesi Farmaceutici), VYJUVEK (Krystal Biotech), JACE (Japan Tissue Engineering), and recently approved ZEVASKYN (Abeona Therapeutics), have been approved for treating DEB, leaving a significant unmet need for effective and targeted dystrophic epidermolysis bullosa treatments.
FILSUVEZ (oleogel-S10), developed by Chiesi Farmaceutici, is a plant-based medicinal product derived from birch bark triterpenes. It was granted EU-wide marketing authorization on June 21, 2022. In December 2023, the FDA approved FILSUVEZ topical gel for the treatment of partial-thickness wounds in patients aged six months and older with Junctional or Dystrophic Epidermolysis Bullosa (JEB and DEB).
VYJUVEK (beremagene geperpavec), developed by Krystal Biotech, is a topical, repeat-dose gene therapy intended to deliver two functional copies of the COL7A1 gene directly to DEB wounds. It received FDA approval in May 2023 for use in DEB patients aged six months and older. The Marketing Authorization Application (MAA) for VYJUVEK has been validated by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) and is currently under review.
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