Posted by Michael Wonder on 30 Aug 2017
Abeona Therapeutics receives FDA breakthrough therapy designation for EB-101 autologous cell therapy in epidermolysis bullosa
29 August 2017 - FDA recently guided company to accelerate Phase 3 trial for EB-101 autologous cell therapy.
Abeona Therapeutics announced today that the U.S. FDA has granted breakthrough therapy designation status to the Company’s EB-101 gene therapy program for patients with recessive dystrophic epidermolysis bullosa.
The designation from the FDA enables collaborative discussions with senior FDA personnel, priority review and an expedited approval process to drug candidates where preliminary clinical trials indicate that a therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases.
