The French National Agency for the Medicines and Health Products Safety (ANSM) granted a Temporary Authorisation for Use (ATU) so-called cohort ATU (cATU) for LEUKOTAC® (inolimomab) on December 24, 2019.
Inolimomab is therefore available to hematologists or to physicians treating blood disorders and to hospital pharmacists for the treatment of acute cortico-resistant or corticosteroid-dependent graft-versus-host disease after allogeneic hematopoietic stem cell transplantation in adults and pediatric patients over 28 days of age. The indication should be discussed during a multidisciplinary consultation meeting.
Lyon, FRANCE, January 9, 2020, ElsaLys Biotech announced today that the cATU has been granted by the ANSM and its clinical experts, after evaluation of a dossier containing data on the quality, safety and efficacy of the drug based on its administration in several hundred patients included in clinical trials or treated via named patient Temporary Authorization for Use (“ATU nominative”) until November 2015. This authorization includes the implementation of a reinforced monitoring (defined in the Protocol for Therapeutic Use) of the efficacy and safety data obtained in patients treated within the framework of this cATU. Inolimomab treatment can only be considered if the patient cannot be included in an ongoing clinical trial.
"We have data that support the benefit of inolimomab treatment in patients with acute corticosteroid-resistant or corticosteroid-dependent graft-versus-host disease (Grades II-IV in Glucksberg classification)," said Dr. David LIENS, Chief Medical Officer, ElsaLys Biotech. "We are delighted with this decision by the ANSM, which allows us to, once again, make inolimomab (1 mg/mL, solution for infusion) available to hematologists in the therapeutic emergency which is this pathology".
"While we continue to work on the filing of marketing authorization applications (MAA) in Europe and in the US, this ATU demonstrates the therapeutic value of inolimomab in the management of acute graft-versus-host disease (aGvHD). The ATU program in France allows patients, whose survival is at stake, to have access to a therapeutic solution before marketing in Europe, in close collaboration with the competent authority, the ANSM. The implementation of this cATU is effective immediately" said Dr. Christine GUILLEN, CEO and co-founder of ElsaLys Biotech.
Considering the potential emergency situation of the indication, it is recommended that hematology specialists anticipate the administrative procedures by contacting the ATU Cell (by Tel: 0800 08 90 81 - Fax: 01 56 59 05 60 or by e-mail: firstname.lastname@example.org) which is at their disposal for any further information or request for a Protocol for Therapeutic Use and collection of information.