Celladon Corporation Receives FDA Fast Track Designation for Its Investigational Agent MYDICAR for the Treatment of Heart Failure
LA JOLLA, Calif., Dec. 12, 2011 /PRNewswire/ -- Celladon Corp., a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, announced today that its investigational product candidate MYDICAR® has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of advanced heart failure.
The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
"The positive results of the phase 2 CUPID Trial demonstrated the potential of MYDICAR® to become an important treatment for patients with chronic, advanced heart failure," said Krisztina Zsebo PhD, President and CEO of Celladon Corp. Dr. Zsebo continued, "Today we are pleased that the FDA recognizes the potential benefit of MYDICAR® to address the enormous unmet medical need for additional therapeutics to treat advanced heart failure patients by granting the program Fast Track Status."
About the CUPID Trial
The previously announced results of the phase 2 CUPID Trial met its primary safety and efficacy endpoints at 6 months for high dose MYDICAR® versus placebo. Additionally, 12 months after receiving a single infusion of MYDICAR®, patients treated with the highest dose versus placebo had an 88 percent risk reduction (Hazard Ratio = 0.12, P=0.003) of major cardiovascular events such as death, need for left ventricular assist device (LVAD) or cardiac transplant, episodes of worsening heart failure and number of heart failure-related hospitalizations.
The mean duration of hospitalization in the MYDICAR® high dose group during the 12-month period was 0.4 days per patient compared with 4.5 days per patient in the placebo group. This finding is especially noteworthy because heart failure is the leading cause of hospitalization in Americans 65 years of age and older.
Additionally, the 12-month CUPID data show that heart failure, which is a progressive disease, became stabilized in patients treated with high dose MYDICAR®: heart failure symptoms, exercise tolerance, serum biomarkers and cardiac function essentially improved or remained the same while these parameters deteriorated substantially in patients treated with placebo and concurrent optimal drug and device therapy.
The safety profile from this study was very favorable, with no significant side-effects from MYDICAR® therapy.
