* 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 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 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
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)