United States: A new drug called Aficamten developed to cure a rare heart condition is likely to go before the Food and Drug Administration (FDA) for approval.
Developed by the pharmaceutical company Cytokinetics, announced that the drug produced “statistically significant and clinically meaningful” results in three of the phase trials of the drug.
The intended benefits of the drug, Aficamten include treatment of hypertrophic cardiomyopathy, a condition that thickens the muscle of the heart and is found in almost 2 percent of the world’s population, as per the National Institute of Health (NIH), as per USA Today News report.
What is Hypertrophic cardiomyopathy?
It is a thickening muscle of a heart condition, which makes it hard for blood to pump, as per the Mayo Clinic.
The reason for the condition is generally genetics and in many cases, it does not even cause any symptoms. If they are experienced, then the symptoms include chest pain, fainting, heart murmur, sensation of fast, fluttering or pounding heartbeats (palpitations), and shortness of breath.
As per the report from USA Today News, the Mayo Clinic recommends seeking immediate medical attention when a person is feeling rapid or irregular heartbeat, difficulty breathing, or chest pain.
Hank Gathers, a Loyola Marymount basketball star, was killed by a cardiac arrest during a game in 1990 and his autopsy found that he had hypertrophic cardiomyopathy.
Moreover, Oklahoma City Thunder draft pick and former Florida Gator and Kansas State Wildcat star Keyonte Johnson was also diagnosed with the condition after collapsing in a game in 2020.
Phase three trial findings
As per the release, patients in the trial experienced improvement in their ability to exercise for longer, and their peak oxygen uptake. Their quality of life. The trial also showed improvement in “clinically meaningful improvements” in the study’s secondary endpoints including the participant’s Kansas City Cardiomyopathy Questionnaire Clinical Summary Score.
According to the Journal of American College of Cardiology, the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score is a test that measures “symptoms, physical and social limitations, and quality of life in patients with heart failure,” USA Today reported.
The cases with serious adverse effects were shown in 5.6 percent of people in the trial arm and 9.3 percent of people in the placebo arm.
The full results of the study would be presented at “an upcoming medical conference,” said the manufacturing company in its first press release. It also mentioned that if the drug made it to the market then it would compete against Bristol Meyer’s drug Camzyos.
Director of the Hypertrophic Cardiomyopathy Center at Lahey Hospital and Medical Center in Burlington, Massachusetts, and principal investigator for the trial, Martin Maron, M.D, said “A therapy like aficamten that improves exercise capacity in a clinically meaningful manner, absent low (left ventricular ejection fraction) events that interrupt treatment, should be a welcome addition for HCM patients as well as the clinicians who treat them.”