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.
Mesoblast Plans Small Trial After Second CRL For GVHD Cell Therapy
Seeking approval for pediatric patients with acute graft-versus-host disease, Mesoblast gets a second US FDA complete response and now says it will seek to get needed data from a small trial in adults.
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