Biologic licence Application (BLA) re-submitted to FDA for approval of Ryoncil (remestemcel-L) to treat children with steroid refractory acute graft v. host disease

The filing comes after Mesoblast was informed by FDA at the end of March that, following additional consideration, the available clinical data from the Phase III study MSB-GVHD001 appears sufficient to support submission of the proposed BLA for remestemcel-L for treatment of pediatric patients with SRaGVHD. As a result, the filing addresses remaining CMC (Chemistry, Manufacturing, and Control) items.

“We have worked closely with the agency and thank them for their ongoing guidance, facilitating the potential approval of Ryoncil and addressing the urgent need for a therapy that improves the dismal survival outcome in children with SR-aGVHD,” said Mesoblast CEO Dr. Silviu Itescu.

FDA granted remestemcel-L Fast Track designation, a process to facilitate the development and expedited review of therapies for serious conditions that fill unmet medical needs, and Priority Review designation, which is given to drugs that treat a serious condition and provide a significant improvement in safety or effectiveness over existing treatments. The BLA resubmission upon acceptance is expected to have a review period of between two and six months from receipt.