Mannkind’s Inhalable Insulin, Afrezza, Put Back on Hold by the FDA

MannKind Corporation has finally received a complete response letter from the FDA regarding its inhalable insulin, Afrezza. (The FDA issues a complete response letter when it completes its review of a New Drug Application, but cannot yet approve the application as is.) What the FDA wants now is a couple more clinical trials with the new form of the inhaler (one in patients with type 1 diabetes and one in patients with type 2 diabetes), with at least one trial including a treatment group using the older form of the inhaler, in order to obtain a head-to-head comparison of the two devices.

Alfred Mann, the CEO of Mannkind, issued the following statement: “As we reported last fall, we have already begun a series of studies of the next-generation device in patients with type 1 (Affinity 1) and type 2 (Affinity 2) diabetes” Still, according to analysts, it could be another two years before the process is completed.


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