LEUKOTAC® development plan
Already 2,300 patients treated with LEUKOTAC® 250 children 280 adult patients in clinical trials > 2,000 patients under Temporary Use Authorisation (upon request from physicians)
LEUKOTAC® (inolimomab) benefitted in France from the approval of the French Agency for pharmaceuticals and healthcare products (ANSM) to be used in the frame of individual temporary use authorisations, thus being possible as long as the product was available, i.e. until 2015. LEUKOTAC® received Orphan Drug Designation in Europe (March 2001) and in the U.S. (October 2002).
Based on the outcomes of the INO107 Phase III clinical trial (see the poster presented at EBMT2018), notably a significant increase in overall survival at one year (+ 37%) and a significantly more favourable safety profile as compared to the off-label drugs currently used by clinicians, ELSALYS BIOTECH acquired the rights of LEUKOTAC® in 2017 with the aim to quickly reach the market.
ELSALYS BIOTECH plans to submit in 2019 an application dossier for registration to the European Medicines Agency (EMA), based on:
- In-depth analysis of the complete data of the INO107 trial
- Available retrospective data on the patients who received LEUKOTAC® in the frame of individual temporary use authorisations between 1990 and 2015,
- Data that will be collected from the future patients treated in the frame of a cohort temporary use authorization that the Company plans to submit to the ANSM in 2018.
- A prospective paediatric trial that will be discussed with the EMA in the frame of a Paediatric Investigation Plan.
Considering that patients are currently facing a therapeutic emergency, based on these data and with the full support of many clinicians specialized in this pathology who have already administered LEUKOTAC®, ELSALYS BIOTECH aims at obtaining a conditional marketing authorisation (preceding the full market authorisation when studies are still ongoing or to be completed). The Company will also submit a Biologics Licence Application (BLA) in 2020 to the Food and Drugs Administration (FDA) in the United States, where no treatment is currently approved in SR-aGvHD.