Novo Nordisk files for regulatory approval of “faster-acting insulin aspart” in the U.S

Treatment Insulin
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PRESS RELEASE

Plainsboro, N.J. (December 9, 2015) – Novo Nordisk today announced the submission to the U.S. Food and Drug Administration of a New Drug Application (NDA) for faster-acting insulin aspart, a mealtime insulin developed for the treatment of adults with type 1 and type 2 diabetes.for the treatment of people with type 1 and type 2 diabetes

The filing is based on results from the ‘onset’ clinical trial program, which involved approximately 2,100 adults with type 1 and type 2 diabetes. The trials evaluated the efficacy and safety of mealtime and after-meal faster-acting insulin aspart to reduce A1C levels and provide postprandial (after-meal) blood sugar control.

“Today’s filing of faster-acting insulin aspart is a step forward in strengthening our mealtime insulin offerings for patients who require mealtime blood sugar control,” said Todd Hobbs, M.D., U.S. chief medical officer, Novo Nordisk. “Faster-acting insulin aspart underscores our continued commitment to developing new treatment options for these patients. We look forward to working closely with the FDA on the submission and are focused on bringing the next generation of our mealtime insulin to market.”

Upon approval, Novo Nordisk intends to make faster-acting insulin aspart available in the pre-filled delivery device FlexTouch® and 10 ml vial.

About Faster-Acting Insulin Aspart
Faster-acting insulin aspart is an investigational mealtime insulin developed by Novo Nordisk for the control of blood sugar levels in adults with type 1 and type 2 diabetes. Faster-acting insulin aspart contains a short-acting insulin and two well-known excipients, a vitamin and an amino acid, to increase the initial absorption rate and an earlier blood sugar lowering effect.

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Hmmm. Competition for Apidra, maybe?

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I sure would love to have a faster acting insulin. Humalog is pretty slow! Well, of course, when I was first diagnosed I was on R, so Humalog was such an improvement, but it just isn’t very fast.

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For me, Apidra is faster than anything else. But if they can do better, I’m very interested.

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Novolog (insulin aspart) is equivalent to Apidra and Humalog. Peaks in about 90 minutes; gone in about 5 hours.

Am I understanding that this new product is faster than the current three “rapid acting analog insulins?” Does this mean there’s a new class? I’ve seen references to Afrezza being an ultra-rapid acting insulin. The press release lacked the important onset, peak, and duration info. What’s up with that?

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I’ll race it with my afrezza

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Is Novo-Nordisk’s faster aspart insulin going to be marginally faster or a lot faster than the current formulations? If it’s just marginally faster, like peaks in 75 minutes and gone in 4 hours, it’s not that interesting. If, however, it peaks in 45 minutes and is gone in 3 hours, that’s a big improvement, especially for the carb-inclined.

I don’t think it’ll match the speedy Afrezza.

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Apidra has been the fastest acting for my daughter, also. As she’s only 13 years old, Afrezza is not an option.

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As someone who can’t use afrezza because of asthma (plus it’s not in Canada), I’d be very interested in an injectable/pumpable insulin that’s faster than the ones available now. I hope if it’s approved in the U.S. it’ll come to Canada shortly after.

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Apidra starts up at the same rate as Novolog for me - I still prefer it, though, since it seems to tail off a lot faster. I’m hoping that this new one will be faster on both ends. I know some time back, I saw Novo Nordisk’s R&D page discussing two faster insulins that were under development.

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I think there are some built in limitations about how fast things can absorb into bloodstream from subq tissues though… I’m afraid there will always be that barrier with subq injections

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Probably, but that’s not to say there can’t be differences that are significant. R takes 40 minutes to start and Apidra 15 for me, so clearly there are variables that can be affected by the formulation. Unquestionably there must be limits, but it’s by no means certain that we know precisely where they lie, yet.

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I remember an article in 1990 that said that we had reached the absolute maximum processor speed that was possible with silicon, so there would be no processors faster than the 100Mhz processors of the time… Then again, they wanted to close the US Patent office is 1900, since everything possible had already been invented.

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Here is some information comparing faster-acting insulin aspart with insulin aspart.

Faster-acting insulin aspart: earlier onset of appearance and greater early pharmacokinetic and pharmacodynamic effects than insulin aspart.

Heise T1, Hövelmann U1, Brøndsted L2, Adrian CL2, Nosek L1, Haahr H2.

Author information

Abstract

AIMS:

To evaluate the pharmacokinetics and pharmacodynamics of faster-acting insulin aspart and insulin aspart in a randomized, single-centre, double-blind study.

METHODS:

Fifty-two patients with type 1 diabetes (mean age 40.3 years) received faster-acting insulin aspart, insulin aspart, or another faster aspart formulation (not selected for further development), each as a single 0.2 U/kg subcutaneous dose, under glucose-clamp conditions, in a three-way crossover design (3-12 days washout between dosing).

RESULTS:

Faster-acting insulin aspart had a faster onset of exposure compared with insulin aspart, shown by a 57% earlier onset of appearance [4.9 vs 11.2 min; ratio 0.43, 95% confidence interval (CI) 0.36; 0.51], a 35% earlier time to reach 50% maximum concentration (20.7 vs 31.6 min; ratio 0.65, 95% CI 0.59; 0.72) and a greater early exposure within 90 min after dosing. The greatest difference occurred during the first 15 min, when area under the serum insulin aspart curve was 4.5-fold greater with faster-acting insulin aspart than with insulin aspart. Both treatments had a similar time to maximum concentration, total exposure and maximum concentration. Faster-acting insulin aspart had a significantly greater glucose-lowering effect within 90 min after dosing [largest difference: area under the curve for the glucose infusion rate (AUC(GIR), 0-30 min) ratio 1.48, 95% CI 1.13; 2.02] and 17% earlier time to reach 50% maximum glucose infusion rate (38.3 vs 46.1 min; ratio 0.83, 95% CI 0.73; 0.94). The primary endpoint (AUC(GIR, 0-2 h)) was 10% greater for faster-acting insulin aspart, but did not reach statistical significance (ratio 1.10, 95% CI 1.00; 1.22). Both treatments had similar total and maximum glucose-lowering effects, indicating similar overall potency.

CONCLUSIONS:

Faster-acting insulin aspart was found to have earlier onset and higher early exposure than insulin aspart, and a greater early glucose-lowering effect, with similar potency.

Here is the link to the full report of the study:

http://onlinelibrary.wiley.com/doi/10.1111/dom.12468/full

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Fortified with our daily vitamins and minerals…what a novel idea.

I wish they would just put the C-peptide back in our insulin.

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My understanding is that they would actually have to add c-peptide, since insulin produced artificially doesn’t have any c-peptide to be taken out.

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This sounds great to me. Even a faster onset with the same duration would be great. Even using Apidra and eating moderate to low GI food, I have to bolus 30-45 (or sometimes more) minutes before eating if I don’t want to spike. I find this nearly impossible to do on many workdays so I end up only pre-bolusing by 20 minutes, which means I put up with significant spikes that then take hours to resolve.

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Based on the glucose clamp paper, it looks like the new insulin is likely to be just about 10-min faster-acting than Novolog.

It’s no Afreeza, but I think that would make some difference for me.

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Of course everyone’s metabolism is their own. Yours may vary. For me, Novolog takes about 30 minutes and Apidra about 15. So a version of Novolog (aspart) that was 10 minutes faster really wouldn’t offer me anything new.