Fast Track Designation Granted for Mydicar for Heart Failure
Celladon announced that the FDA has granted fast track designation for Mydicar for the treatment of advanced heart failure. The designation was based on results of the Phase 2 CUPID trial, which met its primary safety and efficacy endpoints at 6 months for high dose Mydicar vs. placebo. Additionally, 12 months after receiving a single infusion of Mydicar, patients treated with the highest dose vs. placebo had an 88% risk reduction (HR=0.12, P=0.003) of major cardiovascular events such as death, need for left ventricular assist device or cardiac transplant, episodes of worsening heart failure, and number of heart failure-related hospitalizations.
Mydicar is a genetically targeted enzyme replacement therapy intended to restore levels of SERCA2a, a regulator of calcium cycling and contractility. SERCA2a levels decline in all forms of late-stage heart failure resulting in deficient heart function.
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