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The Blog of Drug Discovery News

Brilique…yes, Brilinta…not sure

Earlier this week in a Dec. 14 blog post, I noted that European regulators had given the go-ahead to AstraZeneca’s ticagrelor for the prevention of atherothrombotic events in adult patients with acute coronary syndromes. In that post, I noted it was likely the U.S. Food and Drug Administration (FDA) would make a similar move for Brilinta (as the drug will be known in the United States) as the European Commission did for Brilique (as it will be known in Europe).

Well, today’s decision by the FDA shows why it was a wise move I became a journalist and not a market analyst.

While the FDA didn’t exactly say “No way,” it also didn’t say “Yes.” Instead, we have a solid, “We’re not sure yet.”

More specifically, the FDA has issued a complete response letter (CRL) for the New Drug Application (NDA) for ticagrelor in the United States. In the CRL, the FDA has requested additional analyses of data from AstraZeneca’s PLATO trial. The agency did not request additional studies, clinical studies or otherwise, as a prerequisite for approval of the ticagrelor NDA. At this point, it seems to want the numbers crunched a bit more from the studies that have been conducted.

AstraZeneca has noted that it is evaluating the contents of the CRL and will respond to the agency’s request for additional analyses of the PLATO data as soon as possible. The company reports that it remains confident in the NDA submission for ticagrelor and in its ability to respond to the agency’s questions.

“Our highest priority is to provide the requested PLATO analyses to the FDA and progress to completion of the Brilinta NDA review,” says Martin Mackay, president of research and development for AstraZeneca.

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December 17, 2010 Posted by | Corporate, Government | , , , | Leave a comment

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.

December 14, 2010 Posted by | Corporate | , , , , | Leave a comment