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.

 

 

Read the press release

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