Brilinta Wins Long-Awaited FDA Approval


AstraZeneca's blood thinner, which will compete with Plavix, won approval after several delays last year.

The FDA announced yesterday that it had approved the use of the blood thinner Brilinta (tiacagrelor) to reduce the chance of heart attack and death in patients with acute coronary syndromes. The approval of the drug, which is made by AstraZeneca, comes after the FDA delayed making a decision on it twice—last September and December.

Brilinta, which will now compete with Plavix, the second-best-selling drug in the world, is designed to be taken along with low doses of aspirin. However, a boxed warning on the drug will warn that taking more than 100 milligrams of aspirin per day reduces its effectiveness.

“In clinical trials, Brilinta was more effective than Plavix in preventing heart attacks and death, but that advantage was seen with aspirin maintenance doses of 75 to 100 milligrams once daily,” Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.

The boxed warning will also indicate that Brilinta can cause significant, sometimes fatal, bleeding.

Around the Web

FDA approves blood-thinning drug Brilinta to treat acute coronary syndromes [FDA]

Related Videos
Video 5 - "Real-World Insights: Navigating Cardiac Myosin inhibitors in Practice" - Featuring 1 KOL
A panel of 5 cardiovascular experts
A panel of 5 cardiovascular experts
Video 4 - "Mavacamten in oHCM: Navigating the REMS Program for Safe, Optimal Outcomes "
Video 3 - "Aligning With 2023 ESC Guidelines in oHCM Treatment"
Robert Rosenson, MD | Credit: Cura Foundation
A panel of 5 cardiovascular experts
A panel of 5 cardiovascular experts
Robert Rosenson, MD | Credit: Cura Foundation
Video 2 - "Lessons from EXPLORER-HCM: Unveiling CMIs' Potential in oHCM Treatment "
© 2024 MJH Life Sciences

All rights reserved.