ElsaLys Biotech, a clinical stage company, owned by Mediolanum Farmaceutici Spa, announced today the U.S. Food and Drug Administration (FDA) agreement to start the LEUKOTAC® (inolimomab) submission process for a Biologics License Application (BLA) for the treatment of Steroid-Refractory acute graft-versus-host disease (aGvHD), grade II-IV adult patients.