Coronary Artery Disease

FDA Expands Antiplatelet Indication

The US Food and Drug Administration (FDA) has expanded its indication for ticagrelor (Brilinta) oral tablets; the drug is now approved to reduce the risk of first myocardial infarction (MI) or stroke among patients with coronary artery disease (CAD) at high risk for such events.1 

“Today’s approval brings new hope to patients at risk of experiencing a first heart attack or stroke,” Université de Paris professor Gabriel Steg, MD, said in a press release.2 Dr Steg was the cochair of the THEMIS trial, the results of which led to the drug’s FDA indication expansion.

Results of the phase 3 THEMIS trial showed that patients with CAD and type 2 diabetes mellitus (T2DM) who were at high risk for a first MI or stroke experienced a statistically significant reduction in the primary composite endpoint of major adverse cardiovascular (CV) events at 36 months with aspirin plus ticagrelor, 60 mg, vs aspirin alone. Reductions in MI and stroke were the drivers of the primary composite endpoint.

According to the FDA, although the efficacy of ticagrelor was established in a population with T2DM, its use is not limited to this setting.1

In the trial, the safety profile for ticagrelor was consistent with the drug’s known profile, with there having been an increased risk of bleeding events.

This is the first regulatory approval for aspirin plus ticagrelor dual antiplatelet therapy among patients who have a high CV risk but who do not have a history of MI or stroke.2

“[CAD] is a potentially life-threatening condition that causes significant morbidity in many people,” THEMIS trial cochair Deepak L. Bhatt, MD, MPH, said in a press release.2 “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.”

—Colleen Murphy

References:

  1. US Food and Drug Administration. Supplemental approval – Brilinta (ticagrelor) tablets. NDA 22433/S-028. Accessed June 1, 2020. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022433Orig1s028ltr.pdf
  2. BRILINTA approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease. New release. AstraZeneca. June 1, 2020. Accessed June 1, 2020. https://www.astrazeneca-us.com/media/press-releases/2020/brilinta-approved-in-the-us-to-reduce-the-risk-of-a-first-heart-attack-or-stroke-in-high-risk-patients-with-coronary-artery-disease-06012020.html