December 17th, 2010

FDA Delays Approval of Ticagrelor

Despite widespread expectations of an easy approval, the FDA has issued a complete response letter to AstraZeneca for Brilinta (ticagrelor). According to a press release from the company, the FDA has asked for additional analyses of data from the pivotal PLATO trial, but did not request any additional studies. AstraZeneca said it is evaluating the letter and will respond to the FDA as soon as possible. Despite the highly positive overall results of PLATO, the lack of benefit observed in the U.S. patients enrolled in the trial has been the focus of much discussion and concern.

The company said it remains confident that the drug will eventually gain approval. Wall Street analysts predict that approval of ticagrelor in the U.S. will now be delayed by at least a year.

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