Excerpt from Close Concerns
In a major win for MannKind, the FDA has approved a label update to reflect the faster onset/faster offset of inhaled mealtime insulin Afrezza. The company hosted a call with investors on Monday to discuss the implications of this label change – and there are many! – which is available online as a webcast replay. At a high level, the revised Afrezza label includes clinical trial data to show onset of insulin action within 12 minutes, peak effects within 35-45 minutes, and a return to baseline PK/PD ~1.5 hours after dosing with a 4-unit cartridge or ~3 hours after dosing with a 12-unit cartridge. This reinforces the product’s “ultra-rapid-acting” nature. Faster onset reduces unpredictability around meals for people with diabetes, while faster offset lowers the hypoglycemia risk stemming from residual insulin in the bloodstream (during the investor call, CEO Mr. Michael Castagna highlighted the “long tail” associated with most other mealtime insulin options). Mr. Castagna called this a “pivotal moment” in MannKind’s history, explaining that for the first time, promotional activities around Afrezza will not have to state that the product’s time-action profile is comparable to that of insulin lispro (Lilly’s Humalog).
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