Accueil   Diary - News   All news ElsaLys Biotech announces submission of Biologics License Application to FDA for LEUKOTAC® (inolimomab) for the treatment of graft-versus-host disease in adult patients

ElsaLys Biotech announces submission of Biologics License Application to FDA for LEUKOTAC® (inolimomab) for the treatment of graft-versus-host disease in adult patients

 

The Biologics License Application (BLA) will be reviewed under the FDA’s RealTime Oncology Review pilot program (RTOR program)

 

Lyon, FRANCE, July 23, 2020, 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.

 


The Biologics License Application (BLA) will be reviewed under the FDA’s Real-Time Oncology Review pilot program (RTOR program), an initiative of the FDA's Oncology Center of Excellence. The RTOR program aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible, while maintaining and improving review quality by the FDA.

 

 

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