MannKind Corp. (MNKD)

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by Dr. Sharon Orrange on July 1, 2014 at 10:05am

The FDA just approved Afrezza, an inhaled insulin for both Type 1 and Type 2 diabetics. It will be available for prescription very soon, so will there be a run on it? Here are ten points to keep in mind.
1. The product will be called Afrezza and was developed by the MannKind Corporation.
2. It’s not the first time we’ve heard about inhaled insulin. Exubera, Pfizer’s attempt at inhaled insulin, was never popular because of a possible increase in lung cancer.
3. While we don’t know if there is a connection, there were also more cases of lung cancer in patients taking Afrezza in the clinical trials.

my comment I did not know about the lung cancer.

4. Inhaled insulin will be an expensive medication. How expensive? Don’t know yet.
5. Exubera, the other inhaled insulin, was pulled from the market after 2 years because sales were so low. I never prescribed it. The Exubera device was difficult to use and large. There is reason to believe that it will be different this time. The Afrezza device is small and easy to use.
6. Two other drug companies that were making an inhaled insulin pulled out after the failure of Exubera.
7. Insurance companies may decide to cover Afrezza because the studies of Afrezza show a low risk of hypoglycemia (low blood sugars). Low sugars can lead to substantial cost to insurers so they may embrace Afrezza.
8. Afrezza is a rapid-acting inhaled insulin used prior to meals or within 20 minutes of starting a meal. Remember it is not a substitute for long-acting insulin and must be used in combination with long-acting insulin in patients with type 1 diabetes.
9. Afrezza will have a boxed warning advising that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease. So those folks should stay away from it for now.
10. The work is not done. The FDA is requiring 4 post-marketing studies for Afrezza including a look at use in pediatric patients, and a closer look at the risk for lung cancer.