NEW YORK, June 10 (Reuters) - Bristol-Myers Squibb Co and its partner Pfizer Inc said on Thursday they have halted a big study of their experimental blood clot preventer apixaban due to evidence it prevented stroke among patients with atrial fibrillation.
Bristol-Myers and Pfizer said they plan to halt the Phase III study, called AVERROES, which involved 5,600 patients with the type of irregular heartbeat. It compared the ability of apixaban and aspirin to prevent stroke.
Bristol-Myers said earlier this year it hopes to launch the drug in 2012.
The drugmakers said the study will be stopped early because an interim analysis by an independent data monitoring committee found 'clear evidence' of a reduction in stroke and blood clots in patients.
'This interim analysis also demonstrated an acceptable safety profile for apixaban compared to aspirin,' the companies said in a release. Other drugmakers including Bayer AG and privately held Boehringer-Ingelheim are working on similar drugs that work by blocking a protein called Factor Xa.
Some analysts believe the new crop of drugs have potential to displace warfarin, an anti-coagulant pill that has been the standard of care for more than a half century, but without its high risk of causing dangerous bleeding.
The drugmakers are hoping their products will also be far easier to manage than warfarin, which requires close monitoring and regular blood tests because there is a narrow margin between effective and dangerous doses.
Apixaban is being tested in almost 60,000 patients worldwide to prevent blood clots and strokes, to treat clots, and to prevent repeat heart attacks. It has proven effective in mid-stage trials at reducing blood clots among patients undergoing knee-replacement surgery.
But the biggest commercial potential by far for the drug is in preventing stroke among patients with atrial fibrillation -- a type of irregular heartbeat that causes blood to pool in an upper chamber of the heart, and thereby increase the risk of stroke.
(Reporting by Ransdell Pierson and Bill Berkrot, editing by Matthew Lewis) Keywords: BRISTOL PFIZER/APIXABAN (ransdell.pierson@thomsonreuters.com; +1 646-223-6034; Reuters Messaging: ransdell.pierson.reuters.com@reuters.net) 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.
Bristol-Myers and Pfizer said they plan to halt the Phase III study, called AVERROES, which involved 5,600 patients with the type of irregular heartbeat. It compared the ability of apixaban and aspirin to prevent stroke.
Bristol-Myers said earlier this year it hopes to launch the drug in 2012.
The drugmakers said the study will be stopped early because an interim analysis by an independent data monitoring committee found 'clear evidence' of a reduction in stroke and blood clots in patients.
'This interim analysis also demonstrated an acceptable safety profile for apixaban compared to aspirin,' the companies said in a release. Other drugmakers including Bayer AG and privately held Boehringer-Ingelheim are working on similar drugs that work by blocking a protein called Factor Xa.
Some analysts believe the new crop of drugs have potential to displace warfarin, an anti-coagulant pill that has been the standard of care for more than a half century, but without its high risk of causing dangerous bleeding.
The drugmakers are hoping their products will also be far easier to manage than warfarin, which requires close monitoring and regular blood tests because there is a narrow margin between effective and dangerous doses.
Apixaban is being tested in almost 60,000 patients worldwide to prevent blood clots and strokes, to treat clots, and to prevent repeat heart attacks. It has proven effective in mid-stage trials at reducing blood clots among patients undergoing knee-replacement surgery.
But the biggest commercial potential by far for the drug is in preventing stroke among patients with atrial fibrillation -- a type of irregular heartbeat that causes blood to pool in an upper chamber of the heart, and thereby increase the risk of stroke.
(Reporting by Ransdell Pierson and Bill Berkrot, editing by Matthew Lewis) Keywords: BRISTOL PFIZER/APIXABAN (ransdell.pierson@thomsonreuters.com; +1 646-223-6034; Reuters Messaging: ransdell.pierson.reuters.com@reuters.net) 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.