On June 27, 2014, the FDA approved Afrezza, an inhaled insulin for mealtime use, bringing this form of therapy back to the market after a 7-year absence.1 The approval covers patients with type 1 (T1DM) and type 2 (T2DM) diabetes mellitus, and follows an extensive review process, one that required the drug’s manufacturer, the MannKind Corporation, to perform additional clinical trials at FDA’s behest 3 years ago.2
Inhaled insulin got its first try in 2006, when Pfizer brought Exubera to the market. But the oversized inhaler was cumbersome and unpopular with patients and physicians alike. The product failed miserably and was pulled a year later.
By contrast, Afrezza’s small inhaler fits in the palm of a hand, and T1DM advocates who spoke with Evidence-Based Diabetes Management in May said it appeared MannKind had done its homework with patients this time around.3
“(This) 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,” Jean-Marc Guettier, MD, director of the Division of Metabolism and Endocrinology Products in the Center for Drug Evaluation and Research, said in a statement released by FDA.1
Afrezza is not for every person who requires insulin. FDA’s approval comes with a boxed warning, the strongest type, that the product should not be used by smokers or persons with chronic obstructive pulmonary disorder.1 Nor is Afrezza a substitute for long-acting insulin; rather, it is a mealtime complement for that product for T1DM patients; those with T2DM can use Afreeza with oral therapy. The inhaled product is seen as a means to get T2DM patients who need insulin to use it when they might otherwise avoid it, due to fear of needles.
According to the FDA, the approval includes requirements for 4 postmarketing studies for Afrezza: a clinical trial to evaluate pharmacokinetics, safety, and efficacy in pediatric patients; a clinical trial to evaluate long-term risks of lung cancer and cardiovascular function; and 2 studies to evaluate dose-response and within-subject variability.1References
1. FDA approves Afrezza to treat diabetes [press release]. Silver Spring, MD: FDA; June 27, 2014. http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm403122.htm.
2. Wilemon T. FDA approves inhaled form of insulin. USA Today. http://www.usatoday.com/story/news/nation/2014/06/28/fda-inhaled-insulindiabetes-afrezza/11612739/. Published June 28, 2014. Accessed June 30, 2014.
3. Mehr S. Inhaled insulin’s long journey to commercialization. Am J Manag Care. 2014;20(SP8):SP253-SP254.