NEW DRUG APPROVALS Inhaled Insulin Afrezza For Diabetes

NEW DRUG APPROVALS Inhaled Insulin Afrezza For Diabetes The FDA has approved a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Insulin human inhalation powder (Afrezza, MannKind Corporation) is administered at the beginning of each meal. The product’s safety and effectiveness were evaluated in 3,017 participants—1,026 with type-1 diabetes and 1,991 with type-2 diabetes. The efficacy of mealtime insulin human inhalation powder in adults with type-1 diabetes was compared to mealtime insulin aspart (fast-acting insulin), both in combination with basal insulin (long-acting insulin), in a 24-week study. At week 24, treatment with basal insulin and mealtime inhaled insulin provided a mean reduction in hemoglobin A1c (HbA1c) that met the prespecified noninferiority margin of 0.4%. Insulin human inhalation powder provided less HbA1c reduction than insulin aspart by a statistically significant margin. Insulin human inhalation powder was studied in adults with type-2 diabetes in combination with oral antidiabetic drugs; the efficacy of the inhaled mealtime insulin was compared to placebo inhalation in a 24-week study. At week 24, treatment with insulin human inhalation powder plus oral antidiabetic drugs provided a mean reduction in HbA1c that was greater, by a statistically significant margin, than the HbA1c reduction in the placebo group. Insulin human inhalation powder is not a substitute for long-acting insulin and must be used in combination with long-acting insulin in patients with type-1 diabetes. It is not recommended for the treatment of diabetic ketoacidosis or for patients who smoke. A boxed warning advises that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD). As a result, insulin human inhalation powder should not be used in patients with chronic lung disease, such as asthma or COPD. The most common adverse reactions in clinical trials were hypoglycemia, cough, and throat pain or irritation. The FDA approved insulin human inhalation powder with a risk evaluation and mitigation strategy (a communication plan to inform health care professionals about the serious risk of acute bronchospasm). The FDA is requiring several postmarketing studies, including clinical trials that will evaluate: pharmacokinetics, safety, and efficacy in pediatric patients; the potential risk of pulmonary malignancy; cardiovascular risk; and the long-term effects on pulmonary function. Source: FDA, June 27, 2014