FDA Approves Inhalable Insulin

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On June 27, the US Food and Drug Administration (FDA) approved Afrezza, a first-in-class inhalable insulin/inhaler combination, for adults with diabetes. An FDA advisory panel voted earlier this year in favor of approving Afrezza for the treatment of Type 1 and Type 2 diabetes.

Afrezza, developed by MannKind Corporation, is comprised of an ultrarapid-acting premeal insulin powder and a whistle-size device that the powder is loaded into for inhalation. The insulin, which comes in single-dose cartridges, is administered at the beginning of each meal, “dissolv[ing] rapidly upon inhalation to the deep lung and deliver[ing] insulin quickly to the bloodstream.” Insulin levels peak within 12 to 15 minutes of administration and decline to baseline after roughly 180 minutes.

The safety and effectiveness of Afrezza for treating diabetes was established in two 24-week studies in a total of 3,017 people. In a trial with 1,991 participants with Type 1 diabetes, Afrezza, in combination with long-acting insulin, was found to reduce A1C levels (a measure of blood glucose control over the previous 2–3 months) comparably to the mealtime insulin aspart (brand name NovoLog) in combination with long-acting insulin. And in a trial with 1,991 people with Type 2 diabetes, Afrezza, in combination with oral diabetes medicines, was found to reduce A1C levels to a greater degree than a placebo (inactive treatment) in combination with oral diabetes medicines.

“Today’s approval broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels,” according to Jean-Marc Guettier, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.

The drug label carries a warning stating that acute bronchospasm (tightening of the muscles surrounding the airways) has been observed in people with asthma and chronic obstructive pulmonary disease (COPD) who are using Afrezza. Because of this, the medicine should not be used in those who have a chronic lung disease.

The manufacturer will be conducting several post-marketing trials, including one focusing on the use of Afrezza in children and another evaluating the lung and cardiovascular risk for people using the medicine.

In those with Type 1 diabetes, Afrezza must be used in combination with injected basal (background) insulin. It is not recommended for the treatment of diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body) or in people who smoke.

The most common side effects in people using this medicine are low blood glucose, cough, and throat pain or irritation.

Exubera, an inhalable insulin approved in the United States in 2006, was discontinued by manufacturer Pfizer in 2007. The drug’s high price and bulky inhaler, along with concerns about lung function, led to much lower sales than expected. But according to MannKind, Afrezza is “a very different product, very much a next-generation product,” with an inhaler that is a fraction of the size of the Exubera inhaler.

According to MannKind spokesman Matthew Pfeffer, “our expectation is that [Afrezza] should be priced comparably to current fast-acting insulins delivered in pen form.” It has not yet been determined when Afrezza will hit the market, as MannKind is currently working toward partnering with a pharmaceutical company for distribution of the product.

For more information, see the press releases on the MannKind and FDA websites.

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