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`Pfizer, BMS win blockbuster FDA approval for Eliquis - FierceBiotech
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`Topics: Regulatory
`Pfizer, BMS win blockbuster FDA approval for
`Eliquis
`December 28, 2012 | By Ryan McBride
`
`SHARE
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`The FDA saved one of its biggest approvals of the year until the end of 2012.
`Eliquis, the clot buster from Bristol-Myers Squibb ($BMY) and Pfizer ($PFE),
`garnered the agency's stamp for use in certain patients with atrial f brillation.
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`Bristol and Pfizer--which have suffered from generic competition to the big-selling
`meds Plavix and Lipitor, respectively--have now won approval for the most
`lucrative use of the drug in the world's top healthcare market. The FDA sanctioned
`the bloodthinner for reducing risk of stroke and blood clots in patients with non-
`valvular atrial f brillation, saying that the drug shouldn't be used in patients with
`artificial heart valves or defective heart valves.
`
`Atrial fibrillation (AF), a common irregular heart beat, afflicts more than 5.8 million
`Americans, according the Bristol-Myers, and the ailment spikes their risk of stroke.
`Last year Pfizer and Bristol revealed that in a 18,201-patient study comparing
`Eliquis or apixaban to decades-old warfarin, the new clot buster lowered stroke
`risk by 21%, major bleeding by 31% and mortality by 11%.
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`"Blood clots in the heart can cause a disabling stroke if the clots travel to the
`brain," said Dr. Norman Stockbridge, director of the Division of Cardiovascular and
`Renal Products in the FDA's Center for Drug Evaluation and Research, in a
`statement.
`
`Bristol and Pfizer have a potential mega-blockbuster product on their hands, with
`analysts estimating peak sales of more than $5 billion. The drug faces competition
`from similar drugs such as Xarelto from Johnson & Johnson ($JNJ) and Bayer
`and the bloodthinner Pradaxa from Boehringer Ingelheim. Yet some experts,
`including those cited by Leerink Swann, believe that Eliquis is the top new warfarin
`replacement.
`
`Regulators in the European Union, Canada and Japan approved Eliquis before the
`FDA for the big AF market. The U.S. agency held up approval of the drug in June,
`http://www.fiercebiotech.com/story/pfizer-bms-win-coveted-fda-approval-bloodthinner-eliquis/2012-12-28
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`Pfizer, BMS win blockbuster FDA approval for Eliquis - FierceBiotech
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`Special Report: Eliquis - Blockbuster buzz: 15 top therapies in late-stage
`development | Slideshow: FDA Approvals of 2012
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`Related Articles:
`Japan OKs warfarin alternative Eliquis from BMS, Pfizer
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