MannKind's AFREZZA
On March 16, 2009 MannKind submitted an NDA for their inhalable insulin product, AFREZZA. The drug is an ultra rapid acting form of inhalable insulin with peak plasma concentrations that mimic physiologic mealtime response at 12–14 minutes. The drug has performed well in clinical trials and was originally scheduled for FDA approval on December 29, 2010. However, in December the FDA announced it needed an additional 4 weeks to complete its review. The company received a CRL on January 19, 2011, denying approval of Afrezza as "questions remain that preclude approval in its current form." MannKind also reported the FDA requires 2 additional clinical trials on its next-generation inhaler compared to the MedTone Inhaler to assess "performance characteristics, usage, handling, shipment and storage," updated safety information related to AFREZZA, as well as proposed user training and changes to the proposed labeling of the device, blister pack, foil wrap and cartons.
Read more about this topic: Inhalable Insulin