After years of development and millions of dollars risked on an investment, the Mannkind Corporation has now submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for its inhalable insulin. Using an inhaler device small enough to fit into a purse, the AFRESA® system may finally offer a viable needle free insulin option for millions of people.
From 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. 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.”
If Mr. Alfred Mann can pull this one off, he surely deserves a Nobel for everything he has done for patients.
Product page: AFRESA…
Press release: MannKind Submits NDA for AFRESA for Treatment of Diabetes…
Flashback: Mann’s Inhaled Insulin Passes Big Test…
