Substudy finds AstraZeneca's Brilinta does not require genetic testing

AstraZeneca reported that data from a substudy of the Phase III PLATO trial found that, "unlike sanofi-aventis and Bristol-Myers Squibb's Plavix (clopidogrel)", the effects of its experimental oral antiplatelet drug Brilinta (ticagrelor) on major cardiovascular events were maintained irrespective of certain genetic variations.

The substudy was designed to explore the interaction of CYP2C19 and ABCB1 on Brilinta and Plavix's efficacy and safety among 10 285 patients with ACS who had participated in the PLATO trial and who were genotyped for the genetic variants, AstraZeneca stated. Alfred Bove, immediate past president of the American College of Cardiology, remarked at the European Society of Cardiology congress where the data were presented that "physicians don’t like complications. If I told you there was an alternative to clopidogrel that worked the same way without the variations, they would jump on it."

Meanwhile, results from a separate study presented at the conference showed that Eli Lilly and Daiichi Sankyo's Effient (prasugrel) also worked regardless of gene variations. The findings were based on a smaller analysis of data from the TRITON trial. Both substudies were simultaneously published in The Lancet.

An FDA advisory panel recently recommended approval for Brilinta to treat patients undergoing percutaneous coronary intervention, as well as those being medically managed and not expected to undergo surgical treatment. A decision on the drug by the US regulator is scheduled for September.

In March, the FDA added a boxed warning to Plavix's label about reduced effectiveness in patients who have a variation in the CYP2C19 liver enzyme. Plavix, which recorded sales of $9.8 billion last year, faces generic competition in the US in 2012.

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