FDA Considering Approval for AstraZeneca’s Brilinta

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After positive results obtained from the PLATO study, the FDA is considering approval of AstraZeneca’s Brilinta (generic name ticagrelor) as an alternative to Sanofi-Aventis’ Plavix (clopidogrel). The study found that Brilinta reduced the combination of heart attacks, strokes, and death from cardiovascular causes without an increase in major bleeding complications.

Brilinta is indicated for patients with acute coronary syndromes, or ACS, a term for conditions that result from a reduction in blood flow to the heart muscle. These include chest pain (angina) and heart attack. Antiplatelet drugs, such as Brilinta and Plavix, work by preventing clots that cause these conditions.

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Another benefit to Brilinta is that it requires no genetic testing to check if it will work. Plavix, the second biggest-selling medication in the world, was recently found to be ineffective in those with a genetic alteration that led to poor metabolism of the drug. Studies have indicated that patients with a genetic variability in the CYP2C19 or ABCB1 genes were three times as likely to suffer a heart attack or other serious event within 30 days of getting a stent as patients without the mutations.

The FDA added a “black box” warning to the Plavix label indicating that doctors can either increase the dosage in those poor responders or switch to a different treatment.

Brilinta may be approved in September

The FDA will consider approval for Brilinta on September 16, 2010. In Europe, the trial data was presented to the European Society of Cardiology at its annual meeting over the weekend and was given a “class 1 recommendation” as a treatment option.

"Effect of CYP2C19 and ABCB1 single nucleotide polymorphisms on outcomes of treatment with ticagrelor versus clopidogrel for acute coronary syndromes: a genetic substudy of the PLATO trial"
Prof Lars Wallentin MD, Stefan James MD, Robert F Storey MD, Martin Armstrong PhD, Bryan J Barratt PhD, Jay Horrow MD, Steen Husted MD, Prof Hugo Katus MD, Prof P Gabriel Steg MD, Svati H Shah MD, Prof Richard C Becker MD, for the PLATO investigators
The Lancet, Early Online Publication, 29 August 2010 doi:10.1016/S0140-6736(10)61274-3

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