The Food and Drug Administration (FDA) has approved a new diabetes medication that will help diabetics monitor their blood sugar levels. The drug, MannKind's Afrezza, is an insulin powder meant to be inhaled before eating a meal.
Afrezza provides a fast-acting form of insulin that targets adults with type 2 diabetes, the most common form of the disease. Though the drug has been waiting for three years to be approved, the FDA didn’t make it official until Friday.
“Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin,” Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said in a press 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.”
In order to test the drug, the FDA studied its efficacy on a total of 3,017 study participants, of whom 1,991 had type 2 diabetes.
Over 25 million Americans suffer from type 2 diabetes. The prevalence of diabetes continues to grow, hand-in-hand with unhealthy, sedentary lifestyles, and obesity across the U.S. and the whole world. Over 347 million people worldwide have diabetes, according to the World Health Organization (WHO), and this number is expected to balloon in coming years. As a result, the demand for diabetes treatment is also growing.
Currently, most diabetes patients use an insulin shot in order to get their insulin levels up to speed, but the injection can take up to an hour and a half or longer to begin working. The inhalable insulin, on the other hand, could help reach peak insulin levels within 12 to 15 minutes. However, the FDA notes that Afrezza isn’t a substitute for long-acting insulin, but instead, is merely an option to control insulin levels during eating. In addition, the FDA warns that the drug shouldn’t be used by people who suffer from chronic lung diseases like smoker’s cough or asthma, due to reports of breathing spasms.
According to the FDA press release, further studies will need to be conducted in order to be completely safe about Afrezza’s effects on cardiovascular and pulmonary health. The following studies will need to be completed:
- a clinical trial to evaluate pharmacokinetics, safety, and efficacy in pediatric patients;
- a clinical trial to evaluate the potential risk of pulmonary malignancy with Afrezza (this trial will also assess cardiovascular risk and the long-term effect of Afrezza on pulmonary function);
- two pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials, one to characterize dose-response and one to characterize within-subject variability.