LONDON, Sept 24 (Reuters) - AstraZeneca's new heart medicine Brilinta won a green light from regulators on Europe on Friday, boosting prospects for the group's biggest drug hope.
The European Medicines Agency said it had recommended approval for the drug, which will be sold as Brilique in Europe, for preventing dangerous blood clots in patients with acute coronary syndromes.
Recommendations from the regulator are normally endorsed by the European Commission within a few months.
In the United States, the Food and Drug Administration said on Sept. 15 it needed more time to study the application and would now complete its review of Brilinta by Dec. 16 rather than by Sept. 16 as originally indicated.
AstraZeneca is relying on revenues from Brilinta to offset expiring patents on some of its best-selling medicines.
Industry analysts expect Brilinta's sales to reach $1.95 billion by 2014, according to consensus estimates compiled by Thomson Reuters.
The drug is a competitor for Sanofi-Aventis and Bristol-Myers Squibb's 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.
Plavix and Brilinta both work by stopping blood platelets from sticking together and forming clots that can cause heart attacks and strokes.
(Reporting by Ben Hirschler; editing by Kate Kelland) Keywords: ASTRAZENECA/BRILINTA (ben.hirschler@thomsonreuters.com; Tel: +44 20 7542 5082; Reuters Messaging: ben.hirschler.thomsonreuters.com@reuters.net; www.twitter.com/reutersBenHir) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
The European Medicines Agency said it had recommended approval for the drug, which will be sold as Brilique in Europe, for preventing dangerous blood clots in patients with acute coronary syndromes.
Recommendations from the regulator are normally endorsed by the European Commission within a few months.
In the United States, the Food and Drug Administration said on Sept. 15 it needed more time to study the application and would now complete its review of Brilinta by Dec. 16 rather than by Sept. 16 as originally indicated.
AstraZeneca is relying on revenues from Brilinta to offset expiring patents on some of its best-selling medicines.
Industry analysts expect Brilinta's sales to reach $1.95 billion by 2014, according to consensus estimates compiled by Thomson Reuters.
The drug is a competitor for Sanofi-Aventis and Bristol-Myers Squibb's 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.
Plavix and Brilinta both work by stopping blood platelets from sticking together and forming clots that can cause heart attacks and strokes.
(Reporting by Ben Hirschler; editing by Kate Kelland) Keywords: ASTRAZENECA/BRILINTA (ben.hirschler@thomsonreuters.com; Tel: +44 20 7542 5082; Reuters Messaging: ben.hirschler.thomsonreuters.com@reuters.net; www.twitter.com/reutersBenHir) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.