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Submission of biologics license application to FDA for inolimomab for treatment of steroid-refractory acute GvHD in adult patients

Jul 28, 2020

The U.S. Food and Drug administration (FDA) have agreed to start a submission process for a Biologics License Application (BLA) for inolimomab for the treatment of adult patients with Grade 2–4 steroid-refractory acute graft- versus-host disease (aGvHD). 1This move comes following the demonstration of the significant and durable efficacy of inolimomab in a randomized multicenter phase III study ( INO-0107—EUDRACT 2007-005009-24). While this trial did not meet its primary endpoint (overall survival after 1 year), patients treated with inolimomab showed a more favorable outcome after longer term follow-up compared to those who had received antithymocyte globulin. 2

The BLA will be reviewed under the FDA’s Real-Time Oncology Review pilot program, which aims to make the reviewing process more efficient.

Inolimomab is a monoclonal antibody that targets interleukin-2 (IL-2) and is involved in the development and multiplication of certain white blood cells, including T cells responsible for aGvHD. Inolimomab blocks IL-2 from binding to CD25 by specifically linking to and blocking the receptor on the surface of the T cell, preventing their proliferation.

  1. ElsaLyc Biotech. ElsaLys Biotech announces submission of Biologics License Application to FDA for Leukotac® (inolimomab) for the treatment of graft-versus-host disease in adult patients. Published July 23, 2020. Accessed July 27, 2020.
  2. Socié G, Milpied N, Yakoub-Agha I, et al. Long-term follow-up of a phase 3 clinical trial of inolimomab for the treatment of primary steroid refractory aGVHD.  Blood Adv. 2019;3(2):184-186. DOI: 1182/bloodadvances.2018028282