FDA approves AstraZeneca's Brilinta

The FDA on Wednesday approved AstraZeneca’s Brilinta (ticagrelor) to reduce the risk of cardiovascular death and heart attack in patients with acute coronary syndromes. "In clinical trials, Brilinta was more effective than [Sanofi and Bristol-Myers Squibb’s] 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, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research.

The FDA previously extended its review of the oral antiplatelet compound after data showed that patients in North America fared worse than patients in other countries.

Brilinta was approved with a Risk Evaluation and Mitigation Strategy that states that AstraZeneca must conduct educational outreach with physicians to alert them about the risk of using higher doses of aspirin. Sanford C. Bernstein & Co. analyst Tim Anderson suggested that this may give doctors "one more reason to stick to the gold-standard Plavix." The drug will also carry a boxed warning stating that, similar to other anti-coagulants, Brilinta increases the rate of bleeding and can cause significant bleeding that can sometimes prove fatal.

Anderson indicated that AstraZeneca may "strengthen the image of the brand" by conducting studies to clarify Brilinta's effectiveness in US patients, even though the FDA didn't request such postmarketing trials. "Without putting this issue to rest, and with the label warning as it currently reads, we believe payers in the US will have ammunition to disadvantage Brilinta, especially knowing that US generic Plavix will launch in May 2012," Anderson said. He noted that "the current treatment paradigm in the US is to use high-dose aspirin more often than low-dose aspirin," adding: "What AstraZeneca will effectively be trying to do is change this entrenched behaviour, and this could be difficult."

Brilinta won approval in the EU in December, where it is marketed under the name Brilique, and was approved in Canada last month.

Analysts, on average, expect global sales of Brilinta to reach approximately $1.1 billion in 2015.

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