Mannkind’s Afrezza: Count Your Carbs, Dose Your Insulin, and… Inhale!
Recently, MannKind Corporation submitted a “new drug application” for its inhaled insulin candidate, Afrezza, to the FDA. Afrezza, is an ultra rapid-acting mealtime insulin that is inhaled through a small (fits in the palm of a hand) inhalation device. It has been studied in both type 1 and type 2 diabetes and has just received regulatory approval to initiate studies in children with diabetes. MannKind originally applied for FDA approval with the “MedTone” device and is expecting to hear a final decision from the FDA sometime soon. If approved, the company plans to file a supplemental application with the FDA for a second-generation inhalation device, the “Dreamboat,” by June 2010. If MannKind obtains FDA approval for both devices, the Dreamboat could be in doctors’ offices as early as 2011. It’s important to note that Afrezza wouldn’t be the first inhaled insulin to hit the market. As many readers may remember, a few years ago, Pfizer pulled its inhaled insulin, Exubera, off the market; experts cite many reasons, including inconvenient design, confusing dosing instructions, and cost (for more information on Exubera’s downfall, see Learning Curve from diaTribe #7). On the other hand, MannKind has done everything in its power to differentiate Afrezza from Exubera, stressing its ease of use, efficiency, and safety (specifically, the lack of any lung cancer signal). For now, we are staying closely tuned for any updates on the FDA’s decision to approve or deny Afrezza, and we will follow the drug, if approved, through Test Drive. --ST