AstraZeneca announced today that the FDA had extended the PDUFA date for its highly anticipated antiplatelet drug ticagrelor (Brilinta) for 3 months. The deadline for a decision on the drug’s approval has therefore been moved from September 16 to December 16.
On July 28 the FDA Cardiovascular and Renal Advisory Committee voted 7-1 in favor of approving ticagrelor for the indication of STEMI and NSTEMI patients, but the committee and the FDA were uncertain about how best to apply the results of the pivotal PLATO trial because the overall positive effects of the drug were not observed in the subset of patients enrolled in the US.
Update: One highly knowledgeable expert provided this sensible perspective on the extension:
Given the difficulty of sorting through how to portray the “complicated” efficacy story in the label, and the limited FDA resources (and all the directions they are currently being pulled), and the FDA’s hypersensitivity to criticism from other corporate entities who might want to cry “foul” through their legislative representatives, I can appreciate how they might want to “get it right” the first time and require a little more time to do just that.
Here is the AstraZeneca press release:
US Food and Drug Administration Extends Review Timeline For Brilinta (Ticagrelor) New Drug Application
Published date : 15 September 2010
AstraZeneca today announced that the US Food and Drug Administration (FDA) has extended the time to complete its review of the New Drug Application (NDA) for ticagrelor (BRILINTA).
Accordingly, the FDA extended the Prescription Drug User Fee Act (PDUFA) date from 16 September 2010 to 16 December 2010. AstraZeneca will continue to work closely with the FDA to support the review of the ticagrelor NDA.
Ticagrelor is currently under regulatory review in nine additional territories around the world, including the European Union, Canada, and Brazil.
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