On June 27, 2014, the FDA announced the long-awaited approval of AFREZZA, an insulin delivered by inhalation, for adults with diabetes requiring meal-time insulin.
AFREZZA was developed by MannKind Corporation, whose Chairman/CEO (Al Mann) was the original founder of MiniMed. It consists of freeze-dried regular human insulin along with an inhaler device that resembles a referee’s whistle. The inhaler is disposable and last two weeks after the first use. The cartridges containing the insulin powder come in 4 and 8 unit doses. Although regular insulin is used, its action profile resembles that of rapid-acting insulin analogs (aspart, lispro, glulisine) because of the accelerated route of delivery.
AFREZZA is the second inhalable insulin to be approved in the U.S. Exubera, the brainchild of Pfizer, was pulled off the market several years ago after patients showed little interest and insurance companies were hesitant to pay for it. The fact is, Pfizer never asked the right people about the product before attempting to bring it to market. It was complicated to administer, required a very bulky inhaler device, and did not allow very precise dosing. Apparently, MannKind learned from many of Pfizer’s mistakes. All indications are that AFREZZA is much easier and convenient to administer and takes up less space than insulin pens and disposable needles.
So does this mean it will revolutionize the way we treat and manage diabetes? Hardly.
AFREZZA acts as a rapid-acting mealtime insulin. Basal insulin, delivered via injections or a pump, is still required. Safety is also a potential concern. There is uncertainty about cancer risk and long-term effects on lung function. During clinical trials, some patients experienced an initial decrease in pulmonary function, and nearly 30% reported a cough during use. Two separate 24-week trials found no significant change in A1c between patients using AFREZZA and patients taking injections of rapid-acting insulin. In fact, the FDA submission for AFREZZA classified it as “Non-Inferior” (but not superior) to current rapid-acting insulin. How about that? We can picture the advertising blast: “Come and get it! It isn’t inferior to what you already have!”
Then there’s the issue of dosing precision. AFREZZA doses in 4-unit increments. Can’t take 6 or 9 or 14 units, and you certainly can’t take 1, 2 or 3. Half unit dosing? Fagettaboutit. Unless you’re taking very large doses and it doesn’t matter if you’re off by a few units, the dosing scheme with AFREZZA simply won’t work.
So the bottom line is this…
The only real advantage to using AFREZZA is that it cuts down on the number of needle-sticks required with multiple injection therapy. But how much is that really worth? Today’s insulin syringe and pen needles are so small and thin that they are virtually painless. And we know from experience that a good diabetes educator can teach just about anyone, even the most needle-phobic of patients, to administer insulin injections quite comfortably.
Does AFREZZA really solve a problem? Or is it just another example in a long line of products that sound good in a Board Room discussion but just don’t have practical value? I know many of the people at MannKind. They are bright, industrious people whose intentions are good. I just wish they would put those qualities to better use.
*** Blogger’s note: special thanks to IDS Intern Matthew Schoenherr, whose extensive background research was instrumental in the development of this article.