FDA is requiring a 5-year clinical trial to assess long-term malignancy risk. In already completed trials, 2 patients (with heavy tobacco use) taking Afrezza developed lung cancer and in no comparators. After that, 2 more non-smokers developed lung cancer.
Long-term pulmonary safety of inhaling insulin remains unknown.
From DYAX Website: 'Additionally, based on prior research which shows evidence that the kallikrein-kinin cascade may contribute to diseases beyond HAE, we are using the [p-Kal] assays to identify other potential PKM diseases. Current areas of interest include diabetic macular edema, inflammatory bowel disease and rheumatoid arthritis, among others.'