FDA Approves New Treatment for Diabetes

First Posted: Jun 30, 2014 12:36 AM EDT
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The U.S. Food and Drugs Administration (FDA) has recently approved a new inhaled insulin called Afrezza for patients with diabetes. The treatment works to improve glycemic control in adults and should be taken at the beginning of every meal or within 20 minutes after starting a meal, according to the health organization. 

"Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin," said Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, in a news release. "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."

A clinical trial for the drug was conducted on 1,026 participants with type 1 diabetes and 1,991 patients with type 2 diabetes. Some of the participants in the trial were given Afrezza while others were given mealtime insulin throughout a 24-week-period.

Following the end of the trial, researchers found that patients who were given Afrezza often experienced a mean reduction in HbA1c (hemoglobin A1c or glycosylated hemoglobin, a measure of blood sugar control) that met the pre-specified non-inferioirty margin of 0.4 percent. Afrezza, on the other hand, provided less hBA1c reduction than insulin aspart.

However, the drug does come with some side effects. Researchers note that patients with type 1 diabetes should not use the drug in combination with long-lasting insulin. It is also not recommended for patients who smoke and could potentially increase the risk of cough, throat pain or minor irritations.

Afrezza is manufactured by MannKind Corporation.

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