Biotech Values

[DewDiligence]

FDA Issues CRL for AZN’s Brilinta

[This is yet anther case where the FDA overruled its advisory panel, which endorsed Brilinta by a 7-1 vote in Jul 2010 (#msg-52749102). This PR does not provide much detail, as is typical for CRL PR’s issued by Big Pharma; my conjecture is that the FDA wants further granularity on the North American subgroup in the PLATO study, where Brilinta did not show any benefit relative to Plavix. There’s a lot at stake here for AZN insofar as Plavix is the world’s second-largest-selling drug.]

http://finance.yahoo.com/news/AstraZeneca-Receives-Complete-prnews-1253422928.html?x=0&.v=1

›December 16, 2010, 8:59 pm EST

WILMINGTON, Del., Dec. 16, 2010 /PRNewswire/ -- AstraZeneca (NYSE:AZN) 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.‹