Jun. 12 at 10:31 AM
$MESO Mesoblast gives update on Revascor accelerated approval, Ryoncil label extension
Mesoblast provided an update on continued momentum with FDA regarding both accelerated approval pathway for Revascor in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction and inflammation, and label extension for Ryoncil in adults with steroid refractory acute graft versus host disease. In the first week of June, Mesoblast held a Type B meeting with FDA under its Regenerative Medicines Advanced Therapy designation for Revascor to discuss components of a potential filing for a Biologics License Application.
There was general alignment on items regarding chemistry, manufacturing & controls, potency assays for commercial product release, and proposed design and primary endpoint for the confirmatory trial post-approval. The company will await the final minutes from FDA in order to provide detailed feedback and timelines for potential filing. In early July, Mesoblast has an upcoming meeting with FDA to discuss a pivotal trial of Ryoncil in adults with SR-aGvHD.
This trial will be conducted with the NIH-funded Bone Marrow Transplant Clinical Trials Network, the objective being to extend the product's label from children to adults with SR-aGvHD. Ryoncil is the first and only mesenchymal stromal cell product approved by the FDA for any indication.
