ddn Online

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 | , , ,

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