MannKind Corp. submits NDA for diabetes medication

VALENCIA, Calif. MannKind Corp. announced Monday that it is requesting approval from the FDA for a new diabetes medication.

The new drug application for Afresa (insulin monomer human [rDNA origin]) Inhalation Powder and the Afresa Inhaler is designed to treat adults with type 1 or type 2 diabetes mellitus for the control of hyperglycemia.

MannKind explained that Afresa features a pharmacokinetic profile, which mimicks the release of meal-time insulin observed in healthy individuals. The drug reaches peak insulin levels within 12 to 14 minutes of administration.

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 CEO, MannKind. "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."