Posted by Michael Wonder on 16 Apr 2019
FDA agrees to rolling review of Mesoblast's biologic licence application for its cell therapy in children with steroid-refractory acute graft versus host disease
16 April 2019 - Mesoblast announced today that the FDA has agreed that Mesoblast can submit on a rolling basis a biologics license application for its allogeneic cellular medicine remestemcel-L in children with steroid-refractory acute graft versus host disease.
Mesoblast will submit each module of the application to the FDA on a rolling basis as it is completed. The rolling process will provide opportunity for ongoing and frequent communication, and during this process the Company expects it will be able to adequately address any substantial matters raised by the FDA.
Mesoblast has previously received fast track designation from the FDA for remestemcel-L in steroid-refractory acute graft versus host disease and is eligible for priority review once the filing is completed and accepted by the FDA. Mesoblast expects to submit the first module shortly.
