MannKind Receives FDA Approval for Inhaled Insulin

MannKind Corporation reports that the US Food and Drug Administration (FDA) has approved Afrezza (insulin human) inhalation powder to improve glycemic control in adult patients with diabetes mellitus.

The product consists of Afrezza  inhalation powder delivered using a small inhaler. Administered at the start of a meal, the drug dissolves rapidly upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12 to 15 minutes of administration and decline to baseline by approximately 180 minutes.

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 healthcare professionals about the serious risk of acute bronchospasm associated with Afrezza.

Source: Mannkind Corporation and FDA


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