Posted by Michael Wonder on 12 May 2017
FDA grants fast track designation for Celyad’s ischemic heart failure therapy, C-Cure
11 May 2017 - Designation granted on the strength of the evidence in the subset of patients that were responders at 9 month, further confirmed by the 12 months data recently presented.
Celyad today announced that the U.S. FDA has granted a fast track designation for its C-Cure therapy.
FDA granted fast track designation for reduction in mortality, hospitalisation and improvement of quality of life in patients with chronic heart failure secondary to ischaemic cardiomyopathy with baseline left ventricular end diastolic volumes between 200 and 370 ml as fast track development program.
