FDA approves Afrezza to treat diabetes

The US Food and Drug Administration approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycaemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal. An estimated 25.8 million (18.8 million diagnosed and 7.0 million undiagnosed) people in the US or approximately 8.3 per cent of the population have diabetes.

The drug’s safety and effectiveness were evaluated in a total of 3,017 participants–1,026 participants with type I diabetes and 1,991 patients with type II diabetes. The efficacy of mealtime Afrezza in adult patients with type II diabetes patients 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 Afrezza provided a mean reduction in HbA1c (haemoglobin A1c or glycosylated haemoglobin, a measure of blood sugar control) that met the pre-specified non-inferiority margin of 0.4 per cent. Afrezza provided less HbA1c reduction than insulin aspart, and the difference was statistically significant. Afrezza was studied in adults with type II diabetes in combination with oral antidiabetic drugs; the efficacy of mealtime Afrezza in type II diabetes patients was compared to placebo inhalation in a 24 week study.

EP News Bureau – Mumbai