Posted by Michael Wonder on 23 Jul 2020
ElsaLys Biotech announces submission of biologics license application to FDA for Leukotac (inolimomab) for the treatment of graft versus host disease in adult patients
23 July 2020 - The biologics license application will be reviewed under the FDA’s Real-Time Oncology Review pilot program.
ElsaLys Biotech announced today the U.S. FDA agreement to start the Leukotak (inolimomab) submission process for a biologics license application for the treatment of Steroid-Refractory acute graft-versus-host disease (aGvHD), grade II-IV adult patients.
Inolimomab has shown a robust and long-lasting response Rate in steroid-refractory acute graft versus host disease (SR-aGvHD) in a randomised multi-centre controlled parallel-group Phase 3 study (INO-107 - EUDRACT 2007-005009-24).
