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FDA approves inhaled insulin for diabetes
Product is first inhaled drug designed for treatment of type 1 and type 2 diabetes.
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Patients with diabetes now have a new option for insulin delivery.
The FDA recently approved inhaled human insulin powder (Exubera, Pfizer and Sanofi-Aventis) as a new insulin delivery option for adult patients with type 1 diabetes or type 2 diabetes. This is the first approval for an inhaled insulin delivery system.
“Until now, patients with diabetes who need insulin to manage their disease had only one way to treat their condition,” Steven Galson, MD, MPH, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars.”
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Courtesy of Pfizer |
Inhaled human insulin powder was recommended for approval in September after the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) reviewed data from clinical trials of the drug.
Clinical trials demonstrated that patients using inhaled human insulin powder were often able to reach peak insulin concentration quicker than patients taking some regular insulins.
Peak insulin levels were achieved at an average of 49 minutes with inhaled human insulin powder; peak levels were achieved at an average of 105 minutes with regular insulin.
The studies also demonstrated that the decrease in HbA1c levels seen in patients treated with inhaled human insulin powder was similar to the decrease seen in patients treated with subcutaneous insulin.
During one 24-week study, 23% of patients treated with inhaled human insulin powder and 22% of patients treated with subcutaneous insulin group achieved the target HbA1c level of 7%. Neither treatment achieved a mean HbA1c of less than 7%, which is considered the optimal target level based on guidelines established by the Diabetes Control and Complications Trial (DCCT).
When recommending the drug for approval, EMDAC committee members acknowledged that although a higher percentage of patients achieving the target HbA1c level would be optimal, replicating the results of the DCCT in the clinical setting is not always possible. The committee also noted that inhaled human insulin powder was typically associated with improved HbA1c levels, even if the improvement was not as significant as some members would have preferred.
Pulmonary safety
There had previously been concerns about pulmonary safety in patients treated with inhaled human insulin powder. The FDA said inhaled human insulin powder should not be used by patients who smoke or who have quit smoking within the past six months. The treatment is also not recommended for patients with asthma, bronchitis, or emphysema. Baseline tests for lung function are recommended before beginning treatment with inhaled human insulin powder and should be conducted every six to 12 months after commencing treatment.
The FDA has also asked Pfizer and Sanofi-Aventis to conduct long-term studies to examine the safety of inhaled human insulin powder in patients with underlying lung disease.