FDA approves Afrezza to treat Diabetes Mellitus- Mannkind Corporation
MannKind Corporation announced that the FDA has approved Afrezza (insulin human) Inhalation Powder to improve glycemic control in adult patients with Diabetes Mellitus (Types 1 & 2). Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal, or within 20 minutes after starting a meal.
Afrezza was studied in adults with Type 2 Diabetes in combination with oral antidiabetic drugs; the efficacy of mealtime Afrezza in Type 2 Diabetes patients was compared to placebo inhalation in a 24 week study. At week 24, treatment with Afrezza plus oral antidiabetic drugs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group.
Afrezza is not a substitute for long-acting insulin. Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes, and it is not recommended for the treatment of diabetic ketoacidosis, or in patients who smoke. The FDA approved Afrezza with a Risk Evaluation and Mitigation Strategy, which consists of a communication plan to inform health care professionals about the serious risk of acute bronchospasm associated with Afrezza.
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