CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

July 20th, 2011

Ticagrelor (Brilinta) Gains FDA Approval

The FDA has approved ticagrelor (Brilinta, AstraZeneca). In a press release, the FDA said that the drug was approved to reduce cardiovascular death and MI in patients with acute coronary syndromes.

The drug’s label will include a boxed warning about bleeding risks, and — of considerable significance in light of the enormous amount of discussion about the topic — the label will state that aspirin doses greater than 100 mg/day decrease the drug’s efficacy. Said the FDA’s Norman Stockbridge, the director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research:

“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.”

The FDA said that the drug was approved with a Risk Evaluation and Mitigation Strategy, which will require the company to educate physicians about the risk of using higher doses of aspirin.

Click here to download a PDF of the Brilinta label.

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3 Responses to “Ticagrelor (Brilinta) Gains FDA Approval”

  1. William DeMedio, MD says:
    July 21, 2011 at 6:50 pm

    I will not be the first or last to use it. I will await some postmarketing surveillence data prior to putting it to general use, except for certain special cases e.g. multiple allergies.

    Competing interests pertaining specifically to this post, comment, or both:
    None

  2. Christopher Paul Cannon, MD says:
    July 21, 2011 at 9:26 pm

    The statement of the FDA’s approval is not complete. It should say’it is approved to reduce cardiovascular death or MI …compared to clopidogrel … In patients with acute corionary syndromes . That is how FDA denotes superiority.

    Competing interests pertaining specifically to this post, comment, or both:
    I was a lead investigator of two trials of ticagrelor.

  3. Larry Husten, PHD says:
    July 21, 2011 at 11:07 pm

    Chris, it’s not clear to me whether you are saying the news report is wrong or the FDA was wrong. The press release states:
    ” The U.S. Food and Drug Administration today approved the blood-thinning drug Brilinta (ticagrelor) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS).”

    Can you clarify your point here?