Accueil   Diary - News   All news LEUKOTAC ® (inolimomab) is available again in France

LEUKOTAC ® (inolimomab) is available again in France

 

LEUKOTAC ® (inolimomab) is available again in France, following the granting of cohort ATU for the treatment of graft-versus-host disease, corticosteroid-resistant or corticosteroid-dependent, with grade II-IV


• 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 corticoresistant 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.

 

Read the press release