Early Access Program With Inolimomab in Steroid-refractory Acute Graft Versus Host Disease Grade II-IV in Adults and in Children Over 28 Days of Age
Latest Information Update: 22 Jul 2022
At a glance
- Drugs Inolimomab (Primary)
- Indications Graft-versus-host disease
- Focus Adverse reactions; Expanded access; Therapeutic Use
- Sponsors ElsaLys Biotech
- 19 Apr 2021 New trial record
- 15 Apr 2021 According to an ElsaLys Biotech media release, the company expects to collect clinical benefit and safety profile data through these compassionate use programs, which will support the companys work on the filing of marketing authorization applications (MAA) in Europe and in the U.S.
- 15 Apr 2021 According to an ElsaLys Biotech media release, 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. The indication should be discussed during a multidisciplinary consultation meeting.