AstraZeneca hit as Brilinta misses FDA green light

AstraZeneca Plc's heart medicine Brilinta failed to win approval from US regulators, delaying a vital new product designed to rival Plavix, the world's second-biggest selling drug. The drugmaker said on Friday it had received a so-called complete response letter from the Food and Drug Administration (FDA), requesting additional analyses of clinical trial data but not additional studies.

The market had been widely expecting a green light from the FDA by Dec 16, especially as the deadline for the agency to deliver its verdict had already been postponed once from Sept 16. Astrazeneca shares, which had spiked higher in recent sessions to reach their highest since late October, went into retreat and were down 5 percent at 2,995 pence by 0949 GMT.

Analyst Mark Clark at Deutsche Bank said the setback would delay and reduce confidence in the drug's potential in the United States, where sales of Brilinta had been expected to contribute some 10 percent to group earnings per share by 2015. AstraZeneca is relying on revenue from Brilinta - which has been approved in Europe - to offset expiring patents on some of its best-selling medicines, such as heartburn treatment Nexium and Seroquel for schizophrenia.