Merck 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
News For MRK From The Last 14 Days
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FDA approves Belsomra sleep drug The Food and Drug Administration approved Belsomra tablets for use as needed to treat difficulty in falling and staying asleep. Belsomra is an orexin receptor antagonist and is the first approved drug of this type. Belsomra will be dispensed with an FDA-approved patient Medication Guide that provides instructions for its use and important safety information. Belsomra is a controlled substance because it can be abused or lead to dependence. Belsomra is made by Merck, Sharpe & Dohme.