FDA Rejects Afrezza Inhaled Insulin

Ann Bartlett Health Guide

    Should inhaled insulin be approved?  According to the FDA, the answer appears to be no.


    Here’s the skinny on Afrezza.  Afrezza is a first of its kind, ultra rapid acting insulin.  Afrezza is insulin in a powder form, called technopshere Insulin (TI) particle that is delivered by inhaling it thru the nose.  There are two parts that form Afrezza; TI is one part, the other part is another particle called FDKP, fumryl diketopiperazine.  Together these two particles promote an insulin monomer, instead of an insulin hexamer. The difference between hexamer and monomer would be that monomer insulin would allow for faster uptake. 

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    The difference would be 12-14 minutes peak time, which would be closer to mimicking a healthy non-diabetic person’s pancreas.  Our current rapid acting insulin achieves peak absorption between 20 and 40 minutes.


    Last year, JDRF partnered with Mannkind to use Afrezza in the artificial pancreas trial because part of the success of the artificial pancreas will be having ultra rapid acting insulin!  Afrezza has the ability to be both liquid and powder, which would make it a more versatile option for future diabetes device research.  With all the pump progress, little will change if we can’t have faster acting insulin to work with the improved devices!


    For the moment, FDA has rejected Afrezza, but has said it would like more trials on it’s second generation inhaler, called the Dreamboat, to make sure it is equivalent to it’s first generation inhaler called the MedTone. This is the reason for rejection, really?!  Isn’t that like saying we want to make sure that your Prius is equivalent to your Edsel?


    I give MannKind two thumbs up for its positive response that they will push forward with the trials on the delivery system.  I hope that Alfred Mann, CEO of MannKind (who is 85 years old) makes it to see the day his persistence pays off!  


    The lower number of drug approvals and the example of FDA's

    rigidity to approve the low-glucose suspend pump are most frustrating! Even with Medtronic's low-glucose suspend pump's record of success elsewhere in the world, the FDA refuses to qualify any standards from other countries, or even consider them. We have to be more than patient (pun intended)! The number of rejections and stalls is concerning for those of us living with diabetes.  



Published On: January 20, 2011