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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