Posted by Michael Wonder on 21 Feb 2017
Vericel receives FDA fast track designation for ixmyelocel-T, an investigational product for the treatment of patients with advanced heart failure due to ischaemic dilated cardiomyopathy
21 February 2017 - Vericel Corporation today announced that the U.S. FDA has designated the investigation of ixmyelocel‑T for reduction in the risk of death and cardiovascular hospitalisation in patients with chronic advanced heart failure due to ischaemic dilated cardiomyopathy as a fast track development program.
"Receiving fast track designation highlights both the unmet medical need for improved therapies to treat advanced heart failure due to dilated cardiomyopathy and the significance of the results from the ixmyelocel-T Phase 2b ixCELL-DCM clinical study" said Nick Colangelo, president and CEO of Vericel. "We believe that achieving important regulatory milestones such as fast track designation enhances the value of ixmyelocel-T and our efforts to partner the further development of this program."
