BOSTON (Reuters) – MannKind Corp said on Wednesday that U.S.
regulators have rejected Afrezza, its experimental device to treat
diabetes, and will require two new clinical trials before approving the
product.
MannKind's shares fell 7.3 percent to $9.11 before being halted pending the news.
Afrezza is a whistle-sized inhaler that is designed to deliver a more
effective rapid-acting insulin than injectable products such as Eli
Lilly & Co's Humalog and Novo Nordisk's NovoLog.
The device is the small company's most advanced product. MannKind's
founder and biggest shareholder is Alfred Mann, 85, an entrepreneur who
has pumped roughly $925 million of his personal fortune into the company
to keep it afloat.
As of December 31, roughly 28 percent of the company's regularly traded
shares -- or 21.5 million -- were held "short" by investors betting the
stock would fall.
My fiance's uncle is a manager at MannKind, so this is a popular discussion with his family considering I'm diabetic. The idea of inhaling insulin is a little weird to me though. Hasn't this product been in development for quite some time now? I personally don't believe there is a very bright future for inhalable insulin.
my mom got all excited a few years ago when it was announced that inhaled insulin was being developed..but im with you, i dont think it will work out too well. i wouldn't switch, even if it was approved. i believe there is one or two users who were involved in the trials on juvenation though. there's a big long thread about it somewhere in this forum haha
I'm on the clinical study for the inhaled insulin. I talked to my doctor-this article was a little misleading. Everyone thinks that it means that the FDA rejected the inhaled insulin itself, Afrezza. The FDA ONLY rejected the new smaller inhaler (I went from using one size inhaler to a much smaller one). The are about to start 2 more clinical studies to approve the smaller size device as it seems to be more effective in absorbing the insulin, and much more discreet. They just didn't have enough comparitive data from the old to new inhaler to approve Afrezza. It was originally supposed to be approved 12/29/10, but keeps getting pushed back.
The positive aspect for me is that I don't have to pay for Afrezza while I'm on the clinical study, so this is just more time i can free insulin lol! Once it does get FDA approved, I'll have to start paying for it...
I'm on the clinical study for the inhaled insulin. I talked to my doctor-this article was a little misleading. Everyone thinks that it means that the FDA rejected the inhaled insulin itself, Afrezza. The FDA ONLY rejected the new smaller inhaler (I went from using one size inhaler to a much smaller one). The are about to start 2 more clinical studies to approve the smaller size device as it seems to be more effective in absorbing the insulin, and much more discreet. They just didn't have enough comparitive data from the old to new inhaler to approve Afrezza. It was originally supposed to be approved 12/29/10, but keeps getting pushed back.
The positive aspect for me is that I don't have to pay for Afrezza while I'm on the clinical study, so this is just more time i can free insulin lol! Once it does get FDA approved, I'll have to start paying for it...
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How does it work? Are doses accurate? Do you still take basal insulin?
Inhaled insulin is super easy!! I wish more people were more open to the idea-it's so much easier than injections or the pump. I do still have to inject myself with a 24 hr insulin (Levemir) as the inhaled insulin is basically meant to replace Humalog or any short acting insulin that you use.
The cartridges that you put in the inhaler come in 2 different dosage amounts: 3 units and 8 units. I inhale when my blood sugar is high and at meal times. I always inhale an extra 3 units if my blood sugar is already high before a meal just to make sure it doesn't rise any higher. You just estimate the amount to inhale based on blood sugar, meal size, etc.
It doesn't take long to get used to at all, I got the hang of how to use the inhaler and dosage amounts in just a couple of days. I'm so grateful for this new technology and I really hope more people get the opportunity to use it!