Mesoblast’s SR-aGVHD Trial Collaboration Ensues Despite FDA Rejections

Mesoblast has partnered with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) to conduct a clinical trial of its drug Ryoncil in patients with steroid-refractory acute graft versus host disease (SR-aGvHD). The trial, which will be developed and conducted by BMT CTN, will evaluate Ryoncil in patients aged 12 and older who have not responded to previous treatments such as corticosteroids and a second-line agent. Mesoblast will submit the final protocol to the US Food and Drug Administration (FDA) after it has been reviewed by two committees from the National Heart, Lung, and Blood Institute.

This collaboration follows several setbacks from the FDA, which requested additional data from Mesoblast to approve its biologics license application (BLA) for Ryoncil in the pediatric population. Mesoblast resubmitted the BLA in January 2023, including survival and efficacy data from a pediatric Phase III trial. Ryoncil is already approved for the treatment of SR-aGvHD in Japan, Canada, and New Zealand and is also being developed for other indications. According to GlobalData, Ryoncil is forecasted to generate $206 million in sales by 2029.

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