The FDA approved the first inhaled medication for people with type 1 or 2 diabetes.
The drug, Afrezza, “is a new treatment option for patients with diabetes requiring mealtime insulin,” Dr. 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 news release on Friday.
He said that MannKind Corp.’s Afrezza 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.”
Afrezza is an insulin powder that comes in a single-use cartridge and is designed to be inhaled at the start of a meal or within 20 minutes. MannKind has said that patients using the drug can achieve peak insulin levels within 12 to 15 minutes. That compares to a wait time of an hour and a half or more after patients inject insulin.
The safety and efficacy of Afrezza were studied in 1,026 patients with type 1 diabetes and 1,991 patients with type 2 diabetes. The efficacy of mealtime Afrezza in type 1 diabetes patients was compared to mealtime insulin aspart, both in combination with basal insulin in a 24-week study.
At Week 24, treatment with basal insulin and mealtime Afrezza showed a mean reduction in HbA1c that met the non-inferiority margin of 0.4%. Afrezza provided a statistically significant less HbA1c reduction than insulin aspart.
Afrezza was also evaluated in adults with type 2 diabetes in combination with oral antidiabetic drugs. The efficacy of mealtime Afrezza in type 2 diabetes patients was compared to placebo inhalation in a 24-week study.
At Week 24, treatment with Afrezza in combination with oral antidiabetic drugs provided a mean reduction in HbA1c that was statistically significantly greater vs. the HbA1c reduction seen in the placebo group.
The agency stressed that Afrezza should never substitute for long-acting insulin, and patients with type 1 diabetes must use the drug in combination with long-acting insulin. Smokers should avoid Afrezza, as well, the agency said, and the drug is not to be used in the treatment of a condition called diabetic ketoacidosis.
People with certain lung conditions should also not use Afrezza, due to a dangerous complication called acute bronchospasm. For this reason, the FDA has ordered a warning be placed on the product’s labeling to caution people with chronic obstructive pulmonary disease (COPD) from using the drug. The FDA is also advising that people with asthma avoid Afrezza for the same reason.
According to the FDA, the most common side effects from Afrezza were hypoglycemia (low blood sugar), cough, and throat pain or irritation.
The FDA is requiring several follow-up studies looking at the drug’s long-term safety, including its impact on the heart and lungs.
According to the World Health Organization, roughly 347 million people worldwide have the disease, a chronic condition in which the body either does not make enough insulin to break down the sugar in foods or uses insulin inefficiently.
Diabetes can lead to dangerous complications such as heart disease, vision loss and nerve and kidney problems. Many patients must take injected insulin daily to maintain healthy blood sugar levels.