Updated, Friday December 17, 1 PM– 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 the PLATO data, but did not request any additional studies. AstraZeneca said it is evaluating the letter and will respond to the FDA as soon as possible. The company said it remains confident that the drug will eventually gain approval.
Revising an earlier estimate based on the initial press release, a Leerink Swann analyst said on Friday that the company had “a very high degree of confidence in a rapid response to FDA’s request for add’l data analyses for the Brilinta NDA.” Seamus Fernandez said the company would respond to the FDA in January and predicted approval in 6-9 months. Although details are not yet available, a major concern of the FDA is likely to involve the lack of efficacy of ticagrelor in the pivotal PLATO trial in patients treated in the US.
Here is the AstraZeneca press release:
AstraZeneca receives complete response letter from US FDA for BRILINTA (ticagrelor tablets)
Friday, 17 December 2010
AstraZeneca announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for ticagrelor (BRILINTA).
In the CRL, the FDA requested additional analyses of the PLATO data. The agency did not request that additional studies, including clinical studies, be conducted as a prerequisite for approval of the ticagrelor NDA.
AstraZeneca 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 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,” said Martin Mackay, President, Research & Development, AstraZeneca.