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`Pfizer, BMS win bloddxster FDA qrprovd for Biqis — FierceBr'otech
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`THEEITEGJNIIBTRYSDALYRKIITGI
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`Topics: Regulatory
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`Pfizer, BMS win blockbuster FDA approval for
`Eliquis
`December 28, 2012 | By Ryan McBride
`
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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 (SPFE),
`garnered the agency's stamp for use in certain patients with atrial f brillation.
`
`Bristol and Pfizer—which have suffered from generic competition to the big-selling
`meds Plavix and l_ipitor, 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 fbrillation, saying that the dnrg shouldn‘t be used in patients with
`artificial heart valves or defective heart valves.
`
`Atrial f brillation (AF), a common irregular heart beat, afflicts more than 5.8 million
`Americans, according the BristoLMyers, and the ailment sp kes their risk of stroke.
`Last yea 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 bleedirg by 31% and mortality by 11%.
`
`j-
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`‘Blood clots in the heart can cause a disabling stroke ifthe 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 $5 bilion. The dnrg faces competition
`from similar drugs such as Xarelto from Johnson & Johnson ($J NJ) and Bayer
`and the bloodthinner Pradaxa from Boehringer lngelheim_ Yet some experts,
`includng 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,
`
`titpjlwwwjiercetidechoorrr/storyIplizer—brns—wirvcoveted-fdaa1provd—bloodhimer—eliqisI‘2012-12-28
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`Pfizer, BMS win Hocktnster FDAqxtov:-I for Eliqis - Fiaceliotech
`Kochenderfert ‘I think the main focus of the CAR
`field will be autologous cells...‘
`UPDATED: Hedge fund's attack on troubled Zafgen
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