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Mannkind's Inhalable Insulin, Afrezza, Put Back on Hold by the FDA
Inhalable insulin, Afrezza
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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Categories: Diabetes, Diabetes, Insulin, Type 1 Issues, Type 2 Issues
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Jan 24, 2011
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Diabetes Health
Diabetes Health is the essential resource for people living with diabetes- both newly diagnosed and experienced as well as the professionals who care for them. We provide balanced expert news and information on living healthfully with diabetes. Each issue includes cutting-edge editorial coverage of new products, research, treatment options, and meaningful lifestyle issues.
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Topics
- Diabetic / Diabetes Health
- Type 1 / 1.5 Diabetes
- Type 2 Diabetes
- Blood Glucose / Sugar
- High/Low Blood Sugar / Fast Acting Glucose
- Insulin- Pumps, Pens & Syringes
- Continuous Glucose Monitors, CGM, Infusion Sets
- Type 2 Medications
- Hyperglycemia
- Hypoglycemia
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