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The Blog of Drug Discovery News

And in this corner…Brilique!

It looks like the world’s second-best-selling medication, Plavix, may possibly have some head-to-head competition in the form of Brilique (also known as Brilinta, and known generically as ticagrelor). In the U.S., the FDA extended the time to complete its review of the New Drug Application ticagrelor from Sept. 16 to Dec. 16, but in Europe, the European Commission has granted marketing authorization to the drug for the prevention of atherothrombotic events in adult patients with acute coronary syndromes.

AstraZeneca, the drug’s maker, expects to begin selling the pill in the second half of 2011, once price negotiations are completed with member countries of the European Union, and the company plans to market Brilique based on the results of a study that showed it cut the risk of heart attacks, strokes and death linked to heart disease more than Plavix.

Plavix, which is also known by its generic name clopidogrel, is sold by sanofi-aventis and Bristol-Myers Squibb Co. and posted $9.8 billion in revenue last year, second in sales only to Pfizer Inc.’s Lipitor for lowering cholesterol.

The AstraZeneca study indicates that Brilique, known by the generic name ticagrelor, works regardless of the patients’ genetic makeup, compared with Plavix, which isn’t as effective in patients with a certain genetic variation. Reportedly, AstraZeneca’s drug showed a higher risk of spontaneous major bleeding in the study.

Brilique got a thumbs-up from an FDA advisory panel in the United States, so it is expected that the FDA make a similar marketing decision for the drug as did its European counterpart, in just a couple days. The drug will be known as Brilinta in the United States.

Plavix, which is also known by its generic name clopidogrel, is sold by Sanofi-Aventis SA and Bristol-Myers Squibb Co. and had $9.8 billion in revenue last year, second in sales only to Pfizer Inc.’s Lipitor cholesterol-lowering pill.
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December 14, 2010 - Posted by | Corporate | , , , ,

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