Abeona Therapeutics’ Zevaskyn Receives the US FDA Approval for Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Shots:
- The US FDA has approved Zevaskyn (prademagene zamikeracel) for treating wounds in adult & pediatric RDEB pts based on the intra-pts controlled P-III (VIITAL) trial & has also granted RPD PRV to Abeona, which the company intends to monetize; Zevaskyn to be commercially available in Q3’25
- The P-III Trial assessed Zevaskyn in RDEB pts, meeting its co-1EPs, with ≥50% healing in 81% chronic RDEB wounds vs 16% with SoC & reduced pain per Wong-Baker FACES scale at 6mos.
- Also, a P-I/IIa study showed sustained improvement in 38 chronic wounds in 7 pts with a single application over a 6.9yr. mFU (Range: 4-8yrs.), depicting long-term effects of Zevaskyn
Ref: Abeona Therapeutics | Image: Abeona Therapeutics
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
