FDA fast-tracks heart failure medication omecamtiv mecarbil
Omecamtiv mecarbil, a cardiac myosin activator being manufactured by Amgen and Cytokinetics to treat heart failure with reduced ejection fraction, has been granted a Fast Track designation by the FDA.
The drug is currently the subject of GALACTIC-HF, a phase III heart failure study involving more than 8,000 patients in 35 countries. The study’s top-line results are expected by the fourth quarter of 2020.
“This Fast Track designation represents an important milestone in the development of omecamtiv mecarbil,” David M. Reese, MD, Amgen’s executive vice president of research and development, said in a statement. “Today, half of heart failure patients will die within five years of diagnosis, underscoring the urgent need for new therapies for this grievous condition.”
“We are pleased that the FDA has granted Fast Track designation for omecamtiv mecarbil for the potential treatment of heart failure,” added Robert I. Blum, president and CEO of Cytokinetics. “The prevalence of heart failure is growing with our aging demographics, and GALACTIC-HF is designed to assess the clinical effects of our novel myosin activator in patients meaningfully at risk.”
More information on the Fast Track process is available on the FDA’s website.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.