SEATTLE, June 06, 2018 (GLOBE NEWSWIRE) -- Nohla Therapeutics, a leading developer of universal, off-the-shelf cell therapies for patients with hematologic malignancies and other critical diseases, today announced the European Medicines Agency (EMA) has granted dilanubicel (NLA101) PRIority MEdicines (PRIME) designation for the treatment of patients receiving a Hematopoietic Stem Cell Transplant (HSCT). Nohla was granted Orphan Drug designation for dilanubicel in HSCT by the European Commission in January 2018.
The EMA PRIME program provides enhanced support for the development of medicines that target an unmet medical need and have clinical data demonstrating the potential for a major therapeutic advantage over existing treatments. The program is designed to speed up evaluation of potential treatments to reach patients more rapidly. Under the PRIME program, a marketing authorization application (MAA) for dilanubicel could be eligible for an accelerated regulatory assessment. Since its inception in 2016, only 21% of PRIME requests have been granted by the EMA.
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 (GVHD) and no transplant-related mortality.