Vericel Corporation (NASDAQ:VCEL) has announced the FDA approval of Nexobrid for the treatment of pediatric patients with severe thermal burns. This approval expands the target customer base to include approximately 20 pediatric burn centers in the United States. Nexobrid, initially approved for eschar removal in adults with deep partial-thickness and/or full-thickness thermal burns in December 2022, is now also approved for pediatric use.
The FDA approval for the pediatric indication is based on the results of the Children Innovation Debridement Study (CIDS), a global phase 3 clinical trial, and additional pediatric data from phase 3 and phase 2 studies. The company expects this expansion to have a meaningful impact on overall Nexobrid uptake over time.
Nexobrid is a biologic product containing proteolytic enzymes indicated for eschar removal in adults and pediatric patients with deep partial* and/or full-thickness thermal burns. It provides a less invasive alternative to traditional methods for pediatric burn patients.
Vericel markets three products in the United States, including Nexobrid, MACI® (autologous cultured chondrocytes on porcine collagen membrane), and Epicel® (cultured epidermal autografts).
The most common adverse reactions in adults were pruritus, pyrexia, wound complication, anemia, vomiting, and insomnia, while in pediatric patients, they were pruritus, pyrexia, and vomiting. The safety and effectiveness of Nexobrid have not been established for the treatment of chemical or electrical burns, burns on specific areas, circumferential burns, burns in patients with significant cardiopulmonary disease, and other specific conditions.
Vericel is a leading provider of advanced therapies for the sports medicine and severe burn care markets, combining innovations in biology with medical technologies. Following these announcements, the company's shares moved 1.8%, and are now trading at a price of $46.14. For more information, read the company's full 8-K submission here.
