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Remestemcel-L-rknd Receives FDA Approval for SR-aGvHD in Pediatric Patients
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Key Takeaways
- Remestemcel-L-rknd is the first MSC therapy approved in the U.S. for any indication.
- The FDA's approval targets pediatric patients with steroid-refractory acute graft versus host disease.
The approval makes remestemcel-L-rknd the first approved mesenchymal stromal cell in the United States.
This coverage is ongoing.
Remestemcel-L-rknd (Ryoncil; Mesoblast) received FDA approval for treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients ages 2 months and up to adolescents and teenagers. This approval makes remestemcel-L-rknd the only mesenchymal stromal cell (MSC) therapy in the United States for any indication.1
Graft vs host disease | Image Credit: © NOTE OMG- stock.adobe.com
“Today’s decision marks an important milestone in the use of innovative cell-based therapies to treat life-threatening diseases with devastating impacts on patients, including children,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a news release. “This first mesenchymal stromal cell therapy approval demonstrates the FDA’s commitment to supporting the development of safe and effective products that could improve the quality of life for patients with symptoms that are unresponsive to other therapies.”1
REFERENCES
1. FDA approves first mesenchymal stromal cell therapy to treat steroid-refractory acute graft-versus-host disease. News release. FDA. December 18, 2024. Accessed December 19, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-host?utm_medium=email&utm_source=govdelivery
