September 15, 2010 / 6:43 AM / 7 years ago

UPDATE 1-AstraZeneca's Brilinta faces 3-month U.S. delay

* FDA will now give decision on heart drug by Dec. 16

* AstraZeneca says remains confident in application

* Brilinta is group’s biggest new drug hope

(Adds comment from spokeswoman, background on competition)

ZURICH, Sept 15 (Reuters) - AstraZeneca’s (AZN.L) potential new blockbuster heart drug Brilinta faces a three-month delay in winning U.S. approval, slicing valuable revenue-earning time off the product.

The company said on Wednesday the Food and Drug Administration needed more time to study the application and would now complete its review by Dec. 16 rather than by Sept. 16 as originally indicated.

Brilinta is AstraZeneca’s most important pipeline product and the company is relying on its revenues to offset expiring patents on some of its best-selling medicines.

“We remain confident in the application and will continue to work closely with the FDA,” said spokeswoman Abigail Baron.

    She declined to give any further details about the reasons behind the delay for Brilinta, a drug which has been widely expected by analysts to win a green light from regulators on both sides of the Atlantic.

    Members of a Food and Drug Administration advisory panel voted 7-1 in July to recommend approval of Brilinta for patients suffering from heart attacks or chest pain who need drug therapy or an artery-clearing procedure.

    Industry analysts expect Brilinta’s sales to reach $1.2 billion by 2014, according to consensus estimates compiled by Thomson Reuters.

    The drug is a competitor for Sanofi-Aventis (SASY.PA) and Bristol-Myers Squibb’s (BMY.N) top-seller Plavix, the world’s second-biggest drug with sales last year of more than $9.5 billion, which is off patent in parts of Europe and will lose U.S. patent protection in 2012.

    Brilinta proved superior to Plavix in a key clinical trial presented last year. (Reporting by Ben Hirschler; Editing by David Holmes)

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