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Mesoblast Limited, recently announced that the United States Food and Drug Administration has accepted for priority review the Company’s Biologics License Application filing for RYONCIL, its allogeneic cell therapy for the treatment of children with steroid-refractory acute graft versus host disease.

A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. 

Mesoblast Chief Executive, Dr. Silviu Itescu says that there is a critical need to improve survival outcomes in children suffering from the more advanced stages of this devastating disease. 

Dr. Itescu says that Mesoblast is on track in its preparation for the potential launch of RYONCIL, including meeting its target inventory build and commercial team. 

(Source: Global News Wire, 2020)