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AZ submits Brilinta to FDA for approval

AstraZeneca has submitted a New Drug Application for its investigational antiplatelet drug, ticagrelor, to the US FDA

AstraZeneca(AZ) has submitted a New Drug Application (NDA) for its investigational antiplatelet drug, ticagrelor (which is proposed to go by the trade name of Brilinta), to the US Food and Drug Administration (FDA).

The drug works by reducing major adverse cardiac events in patients with conditions resulting from a reduction of blood flow to the heart, known as acute coronary syndrome (ACS).

The NDA is based on results of a phase III international head-to-head study involving 18,624 patients with ACS. The trial, known as PLATO, compared ticagrelor plus aspirin with clopidogrel (marketed by sanofi-aventis and Bristol-Myers Squibb as Plavix) plus aspirin.

PMLiVE reported that Brilinta outperformed Plavix in the PLATO trial earlier this year.

This week, the FDA issued a warning to patients taking Plavix to avoid using the stomach acid reducer Prilosec/Prilosec OTC (omeprazole). The warning was issued after new data suggested that when patients take both Prilosec and Plavix, the ability of Plavix to block platelet aggregation (anti-clotting effect) may be reduced by about half.

Dr Mary Ross Southworth from the FDA's Center for Drug Evaluation and Research said: "Patients at risk for heart attacks or strokes who use Plavix to prevent platelet aggregation will not get the full effect of this medicine if they are also taking Prilosec."

19th November 2009

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