FDA Approves New Drug for Diabetes Treatment

The Food and Drug Administration (FDA) has announced the approval of a new medication aimed at helping the nearly 26 million people in the country with diabetes.

Known as Afrezza, the drug is a rapid-acting inhaled insulin which users would take before each meal. “Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin,” said Jean-Marc Guettier, MD, who serves as the director of the Division of Metabolism and Endocrinology Products at the FDA Center for Drug Evaluation and Research. “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 statement from the FDA estimated that there are more than 18 million people who have been diagnosed with diabetes in the country and close to seven million who have not been diagnosed. Afrezza was tested on more than 3000 patients including 1,026 with type 1 diabetes and 1991 patients with type 2. In the 24 week study the type 1 patients treated with basal insulin and Afrezza saw a mean reduction in HbA1c (hemoglobin A1c or glycosylated hemoglobin) that met the pre-specified non-infeoriority margin of .4%.

Results of the study showed Afrezza provided less HbA1c reduction than insulin aspart and called the differenrece “statistically significant.” Type 2 patients were treated with a combination of oral antidiabetic drugs along with Afrezza. The results showed a mean reduction in HbA1c that was “statistically significantly greater,” compared to the placebo group used in the study.

According to the FDA Afrezza is not meant to be a substitute for long acting insulin and must be used with long-acting insulin in patients with type 1 diabetes. It is not recommended for treatment of diabetic ketoacidosis or for smokers.

A warning with the product says it should not be used by patients with chronic lung disease including asthma or chronic obstructive pulmonary disease (COPD) as cases of acute bronchospasm have been observed in patients taking the medication. Other reactions to the drug have included hypoglycemia, cough and throat pain or irritation.

Afrezza is manufactured by the MannKind Corporation located in Danbury, CT.