MannKind Corporation was able to win over the advisors to the Food and Drug Administration (FDA). However, the FDA does not have to follow their advisors’ recommendations. The FDA is concerned that the drug may affect lung function. The advisors counter that the inhaled drug is a beneficial alternative to insulin injections and outweigh the FDA’s concerns. It has been a long road for MannKind, as the company has spent over seven years to gain approval for the treatment. The FDA has already rejected this treatment twice.
The FDA has now delayed its decision on Afrezza by three months, until July 15, 2014. Though the FDA historically has followed its advisors’ recommendations, this time frame is to allow the FDA ample time to go over the data that has been provided by MannKind on this drug, as certain dosing and safety questions still remain.
In July 2006, Pfizer came out with an inhaled insulin called Exubera. The device was quite large and inconvenient for the patient. It was about the size of a flashlight (picture above on right). The same question remains for Afrezza, would the inhaled route of delivery prove as effective as injecting insulin through a needle? Regulators saw that only 10% of the insulin got inhaled into the bloodstream, which left them wondering what long-term effect the other 90% would have on the lungs. Exubera came with a label that warned against smoker use, asthmatics use, and recommended regular lung examinations. Diabetes specialists said it was difficult to use because it came in units that were unusual and there were no advantages over less-expensive therapies. One of the biggest cons was that the device could be compared to a bong for smoking marijuana, which could be embarrassing to use in public. Also, compared to showing a patient how to use an insulin pen in five minutes, it would take about an hour to teach a patient to use Exubera. Pfizer’s drug ultimately failed, and it is still unclear if other insulin products that are inhaled will succeed, where Exubera did not.
Would you recommend this new inhaled insulin to your patient?
Posted by: Katherine Tang, PharmD Candidate 2015