US setback for AstraZeneca

17/12/10 19:22 CET

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AstraZeneca has suffered a big setback as its new heart medicine – Brilinta – has failed to win immediate approval from US regulators.

That means a delay of at least nine months for the blood thinner which is a vital new product for AstraZeneca.

The US Food and Drug Administration wants additional analysis of clinical trial data before it can give the go ahead for the drug’s sale there.

Brilinta has already been approved for use in Europe.

AstraZeneca is relying on revenues from the medicine to offset expiring patents on some of its best-selling medicines.

Many industry analysts have forecast Brilinta could achieve peak annual sales of at least one and a half billion euros.

AstraZeneca’s shares slipped six percent.

More about: Markets, Pharmaceutical companies

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