Another heart failure hopeful: Cytokinetics/Amgen med shows phase 2 promise
- In a phase 2 study of 445 patients with heart failure, patients taking Cytokinetics' and Amgen's investigational omecamtiv mecarbil had statistically significant improvements in blood pressure (BP), heart rate, and blood biomarkers.
- In addition, there was evidence of cardiac remodeling, suggested by markedly decreased heart size in omecamtiv mecarbil-treated patients.
- Heart failure is associated with mortality rates ranging from 5% to 75% per year. But despite that broad range, overall survival rates are low. In fact, life expectancy rates for people with heart failure, especially acute heart failure, are worse than they are for many types of cancer.
The roughly 6 million people in the U.S. who are affected by heart failure, in which the heart can't pump enough blood to meet the body's needs, have traditionally been treated with various ACE inhibitors, ARBs, beta-blockers, diuretics, blood vessel dilators, or digoxin, with nothing new on the horizon for at least a decade—until this year.
Amgen broke the impasse in April when the FDA approved Corlanor (ivabridine) for use in patients who have chronic heart failure caused by the lower-left part of their heart not contracting properly. Then in July, the FDA approved Novartis' Entresto (sacubitril/valsartan) tablets for treatment of heart failure with reduced ejection fraction.
And now, Amgen and Cytokinetics are paving the way for the introduction of another treatment option for patients with heart failure—possibly within the next year. 2015 is shaping up to be a milestone year for innovation in a therapeutic space that affects millions and yet faces a dearth of truly effective treatment options.