FDA Approves Blood Thinning Drug for Heart Disease

(Photos8.com)

The Food and Drug Administration approved the blood-thinning drug Brilinta (ticagrelor) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS). Brilinta is a product of AstraZeneca in Wilmington, Delaware.

Brilinta helps prevent the formation of new blood clots, thus maintaining blood flow in the body to help reduce the risk of another cardiovascular event. The medication has been studied in combination with aspirin in doses of 75 to 100 milligrams once daily. A warning to health care professionals and patients alerts that aspirin doses above 100 milligrams per day decrease the effectiveness of the drug.

FDA’s approval is based upon data from the PLATO (A Study of PLATelet Inhibition and Patient Outcomes) clinical trial that compared treatment with BRILINTA to clopidogrel in 18,624 ACS patients worldwide. Clopidogrel is marketed under the brand name Plavix by Sanofi Aventis.

In December, FDA declined to approve the drug, citing the lack of benefit to the 1,400 U.S. participants in the PLATO trial, and requesting additional analyses of the data from the company.

The approval by FDA is contingent on a plan to help ensure that the drug’s benefits outweigh its risks. The company must conduct educational outreach to physicians to alert them about the risk of using higher doses of aspirin. Brilinta will also be dispensed with a guide that informs patients about the medication, to be distributed with each prescription.

Read more: Clinical Trial of Heart Failure Drug Underway Soon

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