SILVER SPRING, Md., July 10 (UPI) -- A new drug for heart failure, Entresto, was given fast-track approval by the Food and Drug Administration based on a study showing it decreased heart failure-related deaths and trips to the hospital by more than 20 percent when used in place of the condition's current standard treatment.
The agency reviewed the drug under its priority review program, which speeds up reviews of drugs to treat serious conditions that show significant improvement over methods already available to doctors.
"For those of us who have been practicing in heart failure, we've been waiting for a day like this for 15 years, which was the last time we had a major breakthrough in the treatment of systolic heart failure," Dr. Sean Pinney, director of the Advanced Heart Failure and Transplantation Program at Mount Sinai Hospital told CBS News. "It reduces heart failure hospitalizations and it helps people with heart failure live longer -- and it's powerful."
The clinical trial of Entresto was the largest ever for a drug to treat heart failure, a condition characterized by the heart's gradually worsening ability to pump enough blood to meet the body's needs. The study's 8,399 participants were given either Entresto or enalapril, the drug currently most often used to treat heart failure.
Researchers in the study found the new drug led to 23 percent fewer hospitalizations for worsening heart failure, and that participants who took Entresto were 18 percent less likely to require intensive care, 31 percent less likely to need intravenous drugs to stimulate heart contraction, and 22 percent less likely to have a heart failure device implanted or need a heart transplant.
Researchers said the reduction in hospitalizations was evident within the first 30 days of the trial, and that Entresto "led to an early and sustained reduction in biomarkers of myocardial wall stress and injury versus ... enalapril."
The most common side effects of the drug were low blood pressure, high blood potassium levels, and poor kidney function. The study also found that Entresto increased the risk of angioedema, an allergic reaction that appears as swelling in the lips or face, for black patients or those who have previously experienced angioedema, the FDA said in a press release.