FDA Approves Inhalable Insulin

On June 27, the US Food and Drug Administration (FDA) approved Afrezza, a first-in-class inhalable insulin/inhaler combination, for adults with diabetes. An FDA advisory panel voted earlier this year in favor of approving Afrezza for the treatment of Type 1 and Type 2 diabetes.

Afrezza, developed by MannKind Corporation, is comprised of an ultrarapid-acting premeal insulin powder and a whistle-size device that the powder is loaded into for inhalation. The insulin, which comes in single-dose cartridges, is administered at the beginning of each meal, “dissolv[ing] rapidly upon inhalation to the deep lung and deliver[ing] insulin quickly to the bloodstream.” Insulin levels peak within 12 to 15 minutes of administration and decline to baseline after roughly 180 minutes.

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The safety and effectiveness of Afrezza for treating diabetes was established in two 24-week studies in a total of 3,017 people. In a trial with 1,991 participants with Type 1 diabetes, Afrezza, in combination with long-acting insulin, was found to reduce A1C levels (a measure of blood glucose control over the previous 2–3 months) comparably to the mealtime insulin aspart (brand name NovoLog) in combination with long-acting insulin. And in a trial with 1,991 people with Type 2 diabetes, Afrezza, in combination with oral diabetes medicines, was found to reduce A1C levels to a greater degree than a placebo (inactive treatment) in combination with oral diabetes medicines.

“Today’s approval broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels,” according to Jean-Marc Guettier, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.

The drug label carries a warning stating that acute bronchospasm (tightening of the muscles surrounding the airways) has been observed in people with asthma and chronic obstructive pulmonary disease (COPD) who are using Afrezza. Because of this, the medicine should not be used in those who have a chronic lung disease.

The manufacturer will be conducting several post-marketing trials, including one focusing on the use of Afrezza in children and another evaluating the lung and cardiovascular risk for people using the medicine.

In those with Type 1 diabetes, Afrezza must be used in combination with injected basal (background) insulin. It is not recommended for the treatment of diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body) or in people who smoke.

The most common side effects in people using this medicine are low blood glucose, cough, and throat pain or irritation.

Exubera, an inhalable insulin approved in the United States in 2006, was discontinued by manufacturer Pfizer in 2007. The drug’s high price and bulky inhaler, along with concerns about lung function, led to much lower sales than expected. But according to MannKind, Afrezza is “a very different product, very much a next-generation product,” with an inhaler that is a fraction of the size of the Exubera inhaler.

According to MannKind spokesman Matthew Pfeffer, “our expectation is that [Afrezza] should be priced comparably to current fast-acting insulins delivered in pen form.” It has not yet been determined when Afrezza will hit the market, as MannKind is currently working toward partnering with a pharmaceutical company for distribution of the product.

For more information, see the press releases on the MannKind and FDA websites.

  • Karen

    This is great news. I have been an insulin dependent Diabetic since July 1970, 44 years. I am ecstatic and look forward to being on this regiment . when will it be available to local Dr’s ?

  • Kenneth Jester

    I have type2 and would like to see about using this new product…i am currently using 45mg twice aday with a slow action called Lantus

  • Karin Morrison

    Yes, I would be interested!!!

    I cannot take any of the medicine by mouth. It tares up my intestines.
    My stomach swells up like a watermelon.

    My legs are swollen… my skin is burning…

    I am tired and desperate. I was diagnosed with
    type 2.

  • Rebecca Alexander

    Great news! If it doesn’t have to be refrigerated it might finally save money!! Buying needle is expensive for lancets each month.

  • Sandy James

    I am an insulin dependant diabetic for over 25 years using bo
    th short & long acting and I would love to know more. I would like to see the costs and try it. I have had friends tell me about reading this and hoping I could have it.

  • Anita Cohen-Williams

    As someone with Type 2 diabetes, and who is not able to lower her blood sugar levels with the oral medications,I would be very interested in trying this inhaler.

    How do I contact the manufacturer?

  • Tracey Johnson

    I have type 1 and would love to try this!!!!

  • Ruth Moore

    I think this is a fabulous addition to the various treatment options for people with type 1 diabetes, especially if it is not heat sensitive. A big concern of mine is the temperature control of my Humalog that I carry with me, particularly living in Florida. Unfortunately I also have asthma and sarcoidosis so I’m going to need to wait for a better option hopefully during my lifetime.

  • John Knichel

    I would be very interested in trying this new medicine. Thank you.

  • lourdes

    Absolutely!!!

    Who wants to stick themselves numerous times a day, if they don’t have to.

    If the inhaler works as well as the pen/syringe, i’m all for it.

  • Diane G

    I would love to use inhaled insulin because the convenience would be totally awesome. It may bring up questions if inhaling in a public restroom though. LoL

  • Mike MacKenna

    Yes, I would be willing to try an inhaler for diabetic control. I am currently using Lantus and Humalog.

  • Bob

    Yes, I would try it IF the effectiveness is at a level with insulin by pen–and IF the price is in the same field. It’s high time for some new technology in delivering insulin. Thanks.

  • Kirk J.

    I would try this product 100%!
    I have been taking long acting and short acting insulin since the age of 15. I have tried the pump and did not like it , but I do get frustrated some days with having to take another shot. I’ve taken about 24,000 or more shots. I would love to have the option of taking it by mouth. I hope this comes to the market soon with the price availability to most everyone.

  • Dan

    I’d love to have an alturnitave to taking shots. I have taken shots since 1970 and would love an option. Been taking 4 shots/day for the last 16 years or so. Hope this works.

  • Joanie S

    I would very much want to try this. My doctor said, “when it is finally approve,” he would prescribe it.

  • Wayne F Rankin

    I would definitely consider a drug studies this insulin

  • Nicola

    I have had type 1 for 44 yrs and luckily am in good shape however after all these years it is getting harder to find injectable places that absorb the insulin well. I would love to have another option!

  • Tanya B.

    I have been a type 1, since I was 11, maybe even earlier, and I wear a pump close to 20 years. I’ve now cursed my younger son as a type 1, too.
    I’m so heart broken. I cry almost every time I think of it. I’d like Grand children, but, I would hate for that curse to be passed on to his children. I’m now 60 years old!!!
    I was abandoned as a child because my mother could not find it in her heart to give me a injection. I never learned to give myself a proper shot, I still screw the syringe in my body, I hate this illness. I now have MS, I can’t catch a brake. At least my son has something to look forward to.
    Please put this on the fast track, so we can stop suffering.

  • Katie

    I am very interested. Was the side effect of weight gain looked at during the trials? Some of the insulins contribute to weight gain. It would be nice if this didn’t…..

  • Joyce

    yes, I think it is great. I use the lantus pen once a day and really like it. I would like the inhaler but I’m sure the price will be staggering. My lantus puts me in the donut hole every year.

  • Doris Trader-Moulden

    I would love to stop pricking my fingers.

  • Sheli

    YESSSSSSSS!!!!!!!

  • Araceli Horton

    I have type 2 diabeties and I am very interested in this product. I am currently on Humolog 3 times a day before each meal and I take Lantus once a day right before bed. I am real curious to see if this can work for me.

  • Larry Bonnet

    Sounds wonderful but at what cost? Will medicare approve ?

  • Teri Deimel

    I am interested in knowing more about inhalable insulin and whether it is appropriate for people who also suffer from asthma.

  • Mario Whaley

    I would definitely be interested in trying. I have type 2 diabetes.

  • Patricia Pursel

    yes I am very interested ! I am also interested in the cost and weight gain details . I am tired of sticking myself 7 times a day sometimes more.

  • Jim Williams

    I am very interested in trying this insulin.

  • ester lucia

    Very interested. I live in South America though so may have to wait