Mesoblast Plans Small Trial After Second CRL For GVHD Cell Therapy

For a second time, the US Food and Drug Administration has told Mesoblast Limited that a biologic licensing application for its cell therapy candidate for pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD) lacks necessary data. On a 4 August analyst call, Mesoblast said it now plans to conduct a small study in high-risk adult GVHD patients that it hopes will meet the agency’s requirements for approval.

The FDA letter comes after the Australian firm apparently attempted to address a 2020 CRL without conducting an additional study as advised at the time