On June 20, Agepha Pharma’s version of colchicine became the first anti-inflammatory drug approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of myocardial infarction, stroke and other significant cardiovascular events.
The news immediately made headlines throughout the United States, with many cardiologists—especially those in the field of preventive cardiology—praising the approval as a key advancement in patient care.
“Approval by the FDA of the first drug to target cardiovascular inflammation is an important step forward for the care of our patients,” Paul Ridker, MD, MPH, a professor of medicine at Harvard Medical School and director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital, said in a statement at the time. “To treat coronary disease effectively, cardiologists must aggressively reduce inflammation and cholesterol.
Researcher says colchicine approval represents ‘a new era of patient care’
A number of organizations also shared their own perspective on the news. The Montreal Heart Institute (MHI), for example, applauded the FDA’s decision while highlighting the role its own researchers played in the approval. Jean-Claude Tardif, MD, a cardiologist with MHI, was the principal investigator of the COLCOT clinical trial, which examined data from nearly 5,000 patients. The study’s findings, published in the New England Journal of Medicine, helped the FDA make its final ruling on colchicine.
“We have known for a long time that inflammation contributes to atherosclerosis and increases cardiovascular risk,” Tardif said in a new statement. “Our COLCOT study and the LoDoCo2 study have demonstrated that by treating inflammation, we can reduce the risk of cardiovascular events in patients who have already experienced a heart attack. The FDA's approval of colchicine confirms that we are entering a new era of patient care, now targeting inflammation as an underlying cause of atherosclerotic coronary artery disease.”
Cardiologist-founded tech specialists praise FDA’s decision to approve colchicine
Caristo Diagnostics, a healthcare technology company founded in 2018 by cardiologists at the University of Oxford, also issued a statement on the drug’s approval. Caristo’s interest comes from the blood, sweat and tears its founders have put into designing and developing solutions for detecting heart inflammation. The company’s CaRi-Heart technology uses advanced artificial intelligence (AI) technology to obtain measurements of coronary inflammation from CCTA exams and identify patients who face a heightened risk of long-term cardiac mortality.
“Inflammation plays an important part in the development of atherosclerosis and is a strong predictor of CVD progression”, Charalambos Antoniades, MD, PhD, Caristo’s chief scientific officer and a professor at the University of Oxford, said in a statement. “The FDA approval of colchicine is an important tool for us to reduce coronary inflammation, a main culprit for heart attack.”
“Identifying patients with coronary artery inflammation at highest risk, independent of other clinical or CCTA features, will be crucial to achieve maximal patient benefit from newly approved anti-inflammatory drugs,” added Keith Channon, MD, the company’s chief medical officer.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.