New Medicines

LeukotacSevere acute steroid-resistant graft versus host disease (GvHD)


New molecular entity
Elsalys Biotech
Elsalys Biotech

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Apr 21Available in France under a temporary authorisation for use. ElsaLys is working on expanding compassionate use programs for inolimomab in a number of European countries. Several early access applications will be submitted. Data on clinical benefit and safety profile collected through these compassionate use programs will support work on the filing of marketing authorization applications (MAA) in Europe and the U.S. [17].
Apr 21ElsaLys Biotech plans to use data on clinical benefit and safety obtained through compassionate use programes to support marketing authorisations in EU and US [18].
Jul 20US FDA agrees to start the 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 [17].
May 20ELSALYS BIOTECH aims at obtaining a marketing authorisation in Europe by 2022. The Company will also submit a Biologics Licence Application (BLA) in 2021 to the Food and Drugs Administration (FDA) in the United States[15].
Feb 19Elsalys states that, once the regulatory strategy is confirmed, the next step is to sign an agreement for Leukotac, which could involve a single partner or regional alliances [14].
Dec 18ElsaLys plan to file in EU in 2019 [12].
Dec 17ElsaLys Biotech is in discussion with the EMA to assess terms of registration at the earliest opportunity. The company is currently preparing requests for compassionate use authorization for patients with severe steroid-resistant aGvHD with different national health authorities. Discussions with the FDA are expected to start 2018 [11].
Oct 17Elsalys Biotech acquires development and commercialisation rights of inolimomab (LEUKOTAC®) from Jazz pharmaceuticals for treatment of steroid-resistant aGvHD [9].
Oct 15Development discontinued based on PIII data analysis [8].
Mar 15PIII trials complete, data expected mid-2015 [7].
Jun 12Remains in PIII development [4].
Jun 12Jazz Pharmaceuticals completes purchase of EUSA Pharma [4].
Jan 10Orphan drug status was granted in the EU in Mar 01 and in the US in Nov 02 (2)


Anti-IL2 receptor monoclonal antibody
Immunosuppressed patients who receive white blood cells from another person are at risk of GVHD [5].
Severe acute steroid-resistant graft versus host disease (GvHD)

Further information


Trial or other data

Jan 19Long term follow up of patients in INO-107 PIII trial found clear advantage in survival with INO-107 compared with anti-thymocyte globulin (ATG), with survival of 30.6% (15/49) patients with INO-107 and 19.6% (10/51) with ATG [13].
Oct 17PIII INO-0107 study still ongoing according to trial register [10].
Mar 13PIII INO-0106 trial to determine overall response rate (CR + PR) at D29 after initiation of inolimomab in 40 pts with primary steroid resistant aGvHD after allogeneic hematopoietic stem cell transplantation is ongoing [6].
Mar 13PIII INO-0107 trial is ongoing [6].
May 08EUSA Pharma initiated a PIII trial to compare the efficacy, tolerability and pharmacokinetics of inolimomab, vs usual care, in the treatment of primary steroid-refractory acute graft-versus-host-disease (aGVHD), following allogeneic stem cell transplantation in adult pts (INO-0107). This randomised, open-labelled, parallel-assessed study will enrol approximately 100 pts in France & Belgium [3].

Evidence based evaluations