Dive Brief:
- MannKind Corp.'s stock rose almost 10% Monday as the market reacted to news the FDA has approved Afrezza, an insulin inhalation powder.
- This approval, which came Friday, represents a significant breakthrough by bringing a completely new mode of administration to the 25.8 million people in the U.S. with diabetes. It has major implications for compliance.
- Afrezza can be used in patients with type 1 or type 2 diabetes. It dissolves immediately upon inhalation into the lungs and delivers insulin into the bloodstream within 12 to 15 minutes.
Dive Insight:
MannKind’s FDA approval for Afrezza has been a long time coming. After FDA rejected the first application in 2011, Mannkind was required to conduct head-to-head comparison trials for Afrezza compared with MedTone Inhaler, which had been previously studied. The main concern was pulmonary safety.