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FDA reviewers question MannKind's Afrezza

March 28, 2014 11:58 PM UTC

FDA reviewers said Afrezza from MannKind Corp. (NASDAQ:MNKD) is effective for Type II diabetes but questioned the product's efficacy in Type I diabetes and raised potential safety concerns. In the Phase III Study 175 in Type II diabetics, the reviewers noted Afrezza was effective compared to placebo in reducing HbA1c, but said efficacy compared to other diabetes treatments was "modest."

The reviewers had trouble "drawing a solid conclusion regarding efficacy" in Type I diabetics, noting that because of missing data from the Phase III Study 171, the "robustness of this analysis is an issue." Additionally, while Afrezza met the threshold of non-inferiority to subcutaneous NovoLog insulin aspart from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) in reducing HbA1c, the reduction was "actually statistically significantly worse" with Afrezza compared to NovoLog. FDA requested the two trials in a 2011 complete response letter for Afrezza. ...