US FDA delays approval of AstraZeneca's Brilinta, asking for more information

Anglo-Swedish drug major AstraZeneca (LSE: AZN) received a setback yesterday, when the US Food and Drug Administration issued a complete response letter with regard to the firm’s New Drug Application for its blockbuster potential blood thinner Brilinta (ticagrelor), which is expected to rival the world’s second best-selling drug, Sanofi-Aventis’ antiplatelet agent Plavix (clopidogrel), with sales of $9.8 billion last year. News of the delay saw the London-headquartered firm’s shares fall 4.7% to £30.04 in morning trading today.

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. Among drugs that will have to contend with generic competition and the gastrointestinal Nexium (esomeprazole) and the antipsychotic Seroquel (quetiapine), which produced combined sales of $9.83 billion in 2009. Analysts at Morgan Stanley have forecast Brilinta could reach peak sales of $3.3 billion, although others project a more modest $2 billion. The FDA decision comes as a surprise, since an advisory panel voted seven to one to support the drug’s approval (The Pharma Letter July 29).

Call for further analysis of PLATO study