Friday marked another step forward for the millions of Americans who struggle with diabetes and managing their blood sugar with insulin; the Food and Drug Administration has approved a form of insulin to be inhaled, rather than injected. The drug Afrezza, developed by MannKind Corporation, was approved for adults with either Type 1 or Type 2 diabetes.
Friday's approval come more than three years after the FDA first asked MannKind to run additional clinical studies on the drug, reports USA Today. Roughly 347 million people worldwide have diabetes, which is a chronic condition in which the body does not produce enough insulin to break down the sugar in foods, or uses insulin inefficiently. Diabetes can lead to heart disease, stroke, blindness, and even death if not maintained.
The new drug, Afrezza, is an insulin powder in a single-use cartridge. It is designed to be inhaled at the beginning of a meal, or within 20 minutes after consumption. The drug can achieve peak insulin levels within 12 to 15 minutes, claims Mannkind. A stereotypical injection of insulin typically takes an hour and a half or more to reach peak levels.
Afrezza has a boxed warning, the strongest kind, that itshould not be used by people with asthma or other chronic lung diseases because of the risk of bronchospasms, reports the New York Times. Mannkind is in the process of conducting research to assess if Afrezza may raise the risk of lung cancer or impair lung function in users.
MannKind is also in the process of providing the drug to the widespread public through agreements with a partner to help market Afrezza.