AstraZeneca: Ticagrelor (Brilinta) Gains FDA Approval 2

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 (ACS).

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, will state that aspirin doses greater than 100 mg/day decreases the efficacy of the drug. 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.

Click here to read the AstraZeneca press release.

Here is the FDA press release:

FDA NEWS RELEASE

FDA approves blood-thinning drug Brilinta to treat acute coronary syndromes
Boxed warning says daily aspirin doses above 100 milligrams decrease effectiveness

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).

ACS includes a group of symptoms for any condition, such as unstable angina or heart attack, that could result from reduced blood flow to the heart. Brilinta works by preventing the formation of new blood clots, thus maintaining blood flow in the body to help reduce the risk of another cardiovascular event.

Brilinta has been studied in combination with aspirin. A boxed warning to health care professionals and patients warns that aspirin doses above 100 milligrams per day decrease the effectiveness of the medication.

“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,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research.

The boxed warning also says that, like other blood-thinning agents, Brilinta increases the rate of bleeding and can cause significant, sometimes fatal, bleeding. The most common adverse reactions reported by people taking Brilinta in clinical trials were bleeding and difficulty breathing (dyspnea).

Brilinta was approved with a Risk Evaluation and Mitigation Strategy, a plan to help ensure that the drug’s benefits outweigh its risks. As part of that plan, the company must conduct educational outreach to physicians to alert them about the risk of using higher doses of aspirin. In addition, Brilinta will be dispensed with a Medication Guide that informs patients of the most important information about the medication. The guide will be distributed each time a patient fills their prescription.

Brilinta is made by AstraZeneca of Wilmington, Del.

For information:

National Heart, Lung and Blood Institute: Heart Attack1

Approved Drug: Questions and Answers2

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Here is a ticagrelor chronology:

Ticagrelor (Brilinta) Chronology:

May 11, 2009: AstraZeneca issues press release announcing top-line results of PLATO

August 30, 2009: Results of PLATO presented at the ESC and published simultaneously in the New England Journal of Medicine

October 30, 2009: In a quarterly update press release, AstraZeneca reports that the North American subgroup in PLATO did not benefit from ticagrelor therapy.

November 19, 2009: AstraZeneca submits NDA for Brilinta to the FDA.

July 27, 2010: Brilinta gets a very mixed review from FDA reviewers prior to an advisory panel.

July 28, 2010: FDA Cardiovascular and Renal Advisory Committee votes 7-1 in favor of approval for ticagrelor. Live blog: Morning, Afternoon

September 15, 2010: FDA extends review of ticagrelor until December

December 6, 2010: Ticagrelor gains European approval (Brilique is the brand name in Europe)

December 16, 2010: FDA issues a complete response letter to AstraZeneca and asks for additional analyses of PLATO (but no new studies)

February 4, 2011: FDA sets new July 20, 2011 PDUFA date for Brilinta

June 27, 2011: A paper in Circulation provides the most detailed analysis yet of the North American subgroup in PLATO and provides some evidence for the theory that the results are explained by the greater use of high dose aspirin in the US.

July 20, 2011: FDA approves ticagrelor (Brilinta). Detail to come.

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2 comments

  1. Pingback: Ticagrelor | DNA Mapping

  2. Pingback: Brilinta | DNA Mapping

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