FDA Delays Decision on Inhaled Insulin Product Afrezza
Advisory panel recommended approval
The FDA has extended the Prescription Drug User Fee Act (PDUFA) date for Afrezza by 3 months to July 15, 2014, to provide time for a full review of information submitted in response to the FDA's requests.
According to the product’s developer (Mannkind Corp.), Afrezza is a rapid-acting mealtime insulin therapy developed to improve glycemic control in adult patients with type 1 or type 2 diabetes. It is a drug–device combination product consisting of Afrezza inhalation powder delivered using a small inhaler.
Administered at the start of a meal, Afrezza inhalation powder dissolves immediately upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12 to 15 minutes of administration, compared with 45 to 90 minutes for injected rapid-acting insulin analogs and 90 to 150 minutes for injected regular human insulin.
The FDA’s delay in reviewing Afrezza comes less than a week after an advisory panel recommended approving the treatment, but said longer-term studies would be required to gauge the risk of lung cancer and other potential side effects.
If approved, Afrezza would be the first inhaled insulin treatment available in the U.S. since 2006.