vTv says FDA advised that azeliragon efficacy be shown in at least 2 trials

According to a regulatory filing, on September 17, 2018, vTv Therapeutics Inc. received a written response from the FDA to its Type C Meeting Request seeking development guidance for azeliragon. In the response, the FDA advised that the efficacy of azeliragon should be demonstrated in at least two adequate and well-controlled trials, unless under the exceptional circumstances in which a single trial might suffice as set forth in the FDA’s guidance document entitled “Providing Clinical Effectiveness for Human Drug and Biological Products.” The company continues to assess all options for the continued development of azeliragon.

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