MannKind Corporation has announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting approval of Afresa (insulin monomer human [rDNA origin]) Inhalation Powder and the Afresa Inhaler for the treatment of adults with type 1 or type 2 diabetes mellitus for the control of hyperglycemia.
There are 23.6 million people in the United States, or 8% of the population, who have diabetes. Diabetes currently affects 246 million people worldwide and is expected to affect 380 million by 2025. Each year, a further 7 million people develop diabetes and 3.8 million people succumb to the disease.
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. However, the feature that distinguishes Afresa from all other insulin products is not the route of administration - it is the pharmacokinetic profile. The large surface area of the lung provides unique access to the circulatory system. The pH-sensitive Afresa particles immediately dissolve upon contact with the lung surface, releasing insulin monomers that rapidly enter the bloodstream. Afresa achieves peak insulin levels within 12-14 minutes of administration, effectively mimicking the release of meal-time insulin observed in healthy individuals, but which is absent or impaired in patients with diabetes.
The 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 2/3 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.
"We are delighted to have reached this important milestone," said Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. "This NDA submission is the culmination of years of clinical research that has supported our long-held belief that Afresa will be a first-in-class ultra rapid-acting insulin with the potential to change the way diabetes is treated."