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MannKind’s Inhaled Insulin Afresa Submitted to FDA

Mar 31, 2009
 

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. Its pharmacokinetic profile make it different then Exubera, which was removed from the market.

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. Its pharmacokinetic profile make it different then Exubera, which was removed from the market.

 

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 mealtime insulin observed in healthy individuals, but which is absent or impaired in patients with diabetes. Its low hypoglycemic effect and rapid action may allow this inhaled insulin to overcome the problems that Exubera had.

altThe 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.
An extensive clinical program for AFRESA®, involving more than 40 separate studies was conducted. Approximately 5,300 subjects participated in the clinical studies, of which more than 2,900 subjects used AFRESA®. Based on our clinical studies, the use of AFRESA® appears to result in the following clinical benefits compared to rapid acting insulin analogs:

  • Comparable A1c reductions
  • Superior postprandial glycemic control
  • Improved fasting glucose control
  • Less hypoglycemia due to better synchronization with meal absorption and glucose elimination
  • Little or no weight gain
  • No adverse effect on pulmonary function

Publisher’s Comment: It will be very interesting to see if the FDA will approve another inhaled insulin after what happened to Exubera.

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