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January 24, 2014
08:20 EDTMRKMerck allergy drug studies met CBER test of meaningful difference, FDA staff say
In briefing documents ahead of the Allergenic Products Advisory Committee meeting scheduled for January 28 to review the Biologics License Application for Merck's Ragwitek sublingual tablet for oral use, FDA staff wrote that studies P05233 and P05234 "met the sponsorís pre-defined criterion for success of a difference in average TCS of -1.80 over the peak ragweed pollen season...In addition, the two studies met CBERís assessment of meaningful differences for allergen immunotherapy." The document also notes that none of the adverse events categorized as serious by investigators or Merck in the studies were considered related to the study drug and that there were no deaths in any of the five clinical development trials of Ragwitek. Reference Link
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