Ticagrelor, sold by AztraZeneca under the name Brilinta, has been approved by the FDA for reducing the risk of a first heart attack or stroke in high-risk coronary artery disease (CAD) patients.
The FDA’s approval was largely based on the THEMIS trial, which found that aspirin and Brilinta could be used together to significantly reduce major adverse cardiovascular events. The trial’s primary findings were published in the New England Journal of Medicine in October 2019.
“Today’s approval of Brilinta is important news for patients with CAD who will now have a new therapy option to reduce the risk of a first heart attack or stroke,” Ruud Dobber, AztraZeneca’s executive vice president of biopharmaceuticals, said in a prepared statement. “This new indication is a further testament to the overwhelming science supporting Brilinta in the management of patients with coronary artery disease at high risk for cardiovascular events.”
“CAD is a potentially life-threatening condition that causes significant morbidity in many people,” Deepak L. Bhatt, MD, MPH, co-chair of the THEMIS trial and executive director of interventional cardiovascular programs at Brigham and Women’s Hospital in Boston, said in the same statement. “The addition of ticagrelor to aspirin offers a new therapeutic option to decrease the likelihood of both heart attack and stroke, a significant advance in our ability to treat these high-risk patients.”
Expanded indications for ticagrelor are also being reviewed by regulatory agencies in the EU, Japan and China, according to AztraZeneca.
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.