The findings of two 52-week studies showed that the investigational ultra rapid acting insulin Afresa Inhalation Powder, combined with basal insulin, is comparable to standard of care therapies in controlling post-meal blood sugar levels, resulting in less weight gain and risk of hypoglycemia for adult patients with diabetes.
Afresa, developed by MannKind, is an ultra rapid acting mealtime insulin therapy with an action profile that mimics meal-related early insulin release. Based on an extensive phase-III clinical program, a New Drug Application (NDA) has been accepted by the FDA. The company requests approval to market Afresa Inhalation Powder and the Afresa Inhaler for use in adult patients with type 1 and type 2 diabetes mellitus for the treatment of hyperglycemia.
John Gerich, Program Director of Clinical Research Center, said: The unique pharmacokinetic profile of Afresa allows this product to rapidly achieve peak insulin levels.
These results indicate that Afresa may be a promising new therapy for patients with type 1 and type 2 diabetes, as it controls post meal-time glucose levels with the added benefits of less weight gain and lower risk of hypoglycemia, he added.