Posted by Michael Wonder on 06 Jun 2018
Nohla receives EMA PRIME designation for dilanubicel (NLA101) to treat haematopoietic stem cell transplant patients
6 June 2018 - First product to achieve PRIME designation for haematopoietic stem cell transplant patients.
Nohla Therapeutics today announced the EMA has granted dilanubicel (NLA101) PRIority MEdicines (PRIME) designation for the treatment of patients receiving a haematopoietic stem cell transplant (HSCT). Nohla was granted orphan drug designation for dilanubicel in HSCT by the European Commission in January 2018.
The dilanubicel PRIME designation was supported by efficacy and safety data from a Phase 2 study in patients with hematologic malignancies who underwent a myeloablative cord blood transplant. The results of this study demonstrated that infusion of dilanubicel was safe and led to faster neutrophil and platelet recovery with excellent long-term survival (86% vs. 66% in a concurrent control group). In addition, dilanubicel-treated patients experienced no severe acute graft-versus-host disease and no transplant-related mortality.
