MannKind, a biopharmaceutical company, has submitted a new drug application to the FDA requesting approval of Afresa inhalation powder and the Afresa inhaler for the treatment of adults with type 1 or type 2 diabetes mellitus for the control of hyperglycemia.
The new drug application (NDA) submission is based on an extensive clinical program, involving 44 completed studies and five ongoing studies at the time of submission. The clinical program included over 5,300 patients. More than 2,450 subjects with type 1 or type 2 diabetes were randomly assigned to treatment with Afresa in the pooled controlled Phase II/III clinical studies.
In addition, the clinical pharmacology program included more than 450 subjects exposed to Afresa in single-dose studies. The extent of exposure meets the current guidance from the FDA regarding the development of therapies for the treatment of diabetes.
According to MannKind, Afresa is an ultra rapid-acting insulin. It is a drug-device combination product, consisting of Afresa inhalation powder pre-metered into single unit dose cartridges and the Afresa inhaler as the delivery device for oral inhalation.
Alfred Mann, chairman and CEO of MannKind, said: We are delighted to have reached this important milestone. This NDA submission is the culmination of years of clinical research that has supported our long-held belief that Afresa will be a ultra rapid-acting insulin with the potential to change the way diabetes is treated.