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`Pfizer, BMS win blodrbuster FDA qmprovd for Eiqis — FierceBiotech
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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 unti the end of 2012.
`Elicpis, the clot buster from Bristol-Myers Squibb ($BMY) and Pfizer ($PFE),
`garnered the agency's stamp for use in certain patients with atrial fibrillation.
`
`Bristol and Pfizer--which have sutfered 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 fibrilation, saying that the dmg shouldn't be used in patients with
`artificial heart valves or defective heart valves.
`
`Atrial fibrilation (AF), a common irregular heart beat, afllicts more than 5.8 million
`Americans, according the Bristol—Myers, and the aiknent spires their risk of stroke.
`Last year Pfizer and Bristol revealed that in a 18,201-patient study comparing
`Eliquis or apixaban to decadesold warfarin, the new clot buster lowered stroke
`riskby21%,majorbleedingby31%andrnortaIityby11%.
`
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`a “Blood cbts in the heart can cause a disabling stroke if the clots travel to the
`Rev,“
`braii,“ said Dr. Nonnan 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 drug faces competition
`from similar drugs such as Xarelto from Johnson & Johnson (SJNJ) and Bayer
`and the bloodthinner Pradaxa from Boehringer lngelheim. Yet some experts,
`including those cited by Leeriik Swann, believe that Eliquis is the top new warfarii
`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,
`titpjlwwwfiercebiotecttcorn/story/pfizer-bins-win-covaed-Ida-qaprovelbloodtimer-eliqjsf2012- 12-28
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`Phase III study of more than 18,000 patients known as "Aristotle." Yet today's FDA
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`Pfizer, BMS win blockbuster FDA qaprova fa’ Eiqis - FierceBiotech
`Kochenderfer. 1 think the main focus of the CAR
`field will be autologous cells...‘
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`development | Slideshowz FDA Approvals of 2012
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