Skip to main content

While ElsaLys continues to work on the filing of marketing approval in Europe and the U.S. for inolimomab, the company confirms the renew of its cohort ATU in France and compassionate use programs submissions in several other countries

-
  • During its first year under ATU and despite the pandemic, around 30 patients in France has been treated with inolimomab as it is considered a reliable treatment for acute cortico-resistant or corticosteroid-dependent graft-versus-host disease in adults and pediatric patients over 28 days of age.

  • ElsaLys is working on expanding compassionate use programs for inolimomab in several other countries in Europe.

 

Lyon, FRANCE, April 15, 2021, ElsaLys Biotech confirmed that The French National Agency for the Medicines and Health Products Safety (ANSM) has renewed the Temporary Authorisation for Use (ATU) so-called cohort ATU (cATU) for inolimomab (LEUKOTAC®) on December 24, 2020.

This renewed 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 is available to hematologists and physicians treating blood disorders and to hospital pharmacists for the treatment of acute cortico-resistant or corticosteroid-dependent graft-versus-host disease in adults and pediatric patients over 28 days of age. The indication should be discussed during a multidisciplinary consultation meeting. Inolimomab treatment can only be considered if the patient cannot be included in an ongoing clinical trial.

During its first year of administration under cATU and despite the pandemic, around 30 patients in France have been treated with inolimomab as it is considered a reliable treatment of this high-risk patient population.The number of patients included in the cohort ATU in France since December 2019 reflects a real medical need. This is the reason why ElsaLys is working on expanding compassionate use programs for inolimomab in a number of  European countries. Several early access applications will be submitted.

" Inolimomab is already being administered in France before marketing autorisation in Europe and hopefully soon in other countries through compassionate use programs as it is considered a reliable treatment of this high-risk patient population with acute cortico-resistant or corticosteroid-dependent graft-versus-host disease.” said Dr. Christine GUILLEN, CEO and co-founder of ElsaLys Biotech. " Data on clinical benefit and safety profile we expect to collect through these compassionate use programs will support our work on the filing of marketing authorization applications (MAA) in Europe and in the U.S.”

STAY IN TOUCH WITH OUR LATEST NEWS

Subcribe to our newsletter

Copyright 2021 ElsaLys Biotech SA

twitter    linkedin

This website uses cookies to track its audience and improve its content.

By continuing to browse this website, you agree to the use of such cookies.