Q4 2024
Newsletters and Drug Reports

Newly Approved Zevaskyn

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Abeona Therapeutics Inc. has announced it has received approval from the US Food and Drug Administration (FDA) for Zevaskyn™ (prademagene zamikeracel, pz-cel), an autologous cell-based gene therapy for adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). Zevaskyn has a Wholesale Acquisition Cost (WAC) of $3.1 million. It will be available through Qualified Treatment Centers beginning in the 3rd quarter of 2025.

 

With mutations in both copies of the COL7A1 gene that expresses Type VII collagen, people with RDEB have extremely fragile skin characterized by extensive blistering and severe wounds that often cover more than 30 percent of a patient’s body surface, and in some cases up to 80 percent. RDEB wounds cause debilitating pain and systemic complications impacting the length and quality of life. These wounds are difficult to heal, can remain open for years, and many that do close tend to reopen. To date, the widely estimated incidence (0.2-6.65 per million births) and prevalence (3.5-20.4 per million people) of RDEB has been primarily characterized by limited analyses of clinical databases or registries.

 

ZEVASKYN consists of a patient’s own skin cells (keratinocytes) that have been genetically modified, to produce functional Type VII collagen. ZEVASKYN sheets are surgically applied to the patient’s wounded areas. In a single application of ZEVASKYN, up to 12 credit card-sized sheets can be joined together to cover large areas or applied to multiple distinct wounds, allowing for significant coverage of affected body areas.