New PDUFA date for AstraZeneca's Brilinta in the USA

In another delay for the approval of Anglo-Swedish drug major AstraZeneca’s (LSE: AZN) potentially blockbuster blood thinner Brilinta (ticagrelor), the company revealed this morning that the US Food and Drug Administration has acknowledged receipt of the company’s reply to the Complete Response Letter (CRL) for the drug’s New Drug Application. Accordingly, the agency has accepted AstraZeneca’s resubmission of the ticagrelor NDA, categorised it as a Class 2 resubmission to the CRL, and set a new PDUFA date of 20 July 2011.

The FDA issued the CRL late last year (The Pharma Letter December 17, 2010). In the CRL, the FDA requested additional analyses of the PLATO data. There appear to be some concerns that Brilinta is not as effective in American patients as those of other populations. The agency did not request that additional studies, including clinical studies, be conducted as a prerequisite for approval of the ticagrelor NDA, the drugmaker said at that time. On January 21 this year, AstraZeneca announced it had submitted the requested supplementary analyses as part of its CRL response.

Ticagrelor is already cleared for marketing – under the trade name Brilique - in Europe for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS; TPL December 6, 2020). Assuming eventual US approval, Brilinta is expected to rival the world’s second best-selling drug, Sanofi-Aventis’ antiplatelet agent Plavix (clopidogrel), which had sales of $9.8 billion in 2009. AstraZeneca is facing a batch of patent expiries over the next four year, and Brilinta had been seen as a product to compensate for the ensuring loss in revenues. A recent study by EvaluatePharma suggests that the company is exposed to patent expiries worth $8.3 billion in the next three years (TPL February 3).