June 23, 2015

Toujeo, a More Concentrated Version of Lantus Is Now Available

As most of you may know, Lantus, the most commonly prescribed basal insulin, saw its patent protection expire in February of this year. Several new competitors in the basal insulin niche are waiting in the wings, hoping to siphon off some of the $9 billion a year the French firm Sanofi has been earning from Lantus.

Two brand new basal insulins currently on deck are Novo Nordisk's Tresiba and a peglispro, from Lilly. Tresiba has been already available in Europe since 2013 but is not approved in the U.S.. It achieves similar blood sugar results as Lantus while claiming to produce fewer nighttime hypos.

Peglispro is not yet approved anywhere yet, and its approval appears to be getting delayed due to some troubling signs found in clinical trial data that suggest it may harm the liver and that it may cause more severe hypos than existing basal insulins.

Besides these new analog insulins, there is another kind of competitor ready to take away Lantus' market share: biosimilars. These are protein molecules that claim to be similar in action, though not identical in structure, to another drug. They are as close as we can get to a generic product with hormones like insulin.  Lilly, in partnership with Boehringer Ingelheim, has already received approval to market its biosimilar insulin glargine, Basaglar in Europe and has tentative FDA approval to market it in the U.S. though because of a patent dispute with Sanofi, it can't bring Basaglar to market in the U.S. until mid 2016. .

What is Toujeo?

To defend itself against this dramatic ramp up in competition, Sanofi has come out with its own "new" basal insulin, which it is calling Toujeo. However, Toujeo is not really a new insulin, as it uses the same molecule, insulin glargine, as Lantus. All that is different is that it now comes in a more highly concentrated form.  Regular Lantus is a U100 insulin, which means there are 100 units of the insulin in every 1 milliliter of solution. Toujeo, in contrast, is a U300 insulin. So there are 300 units in every milliliter.  This means you inject a smaller amount of fluid to get the dose of insulin you need and may change the speed with which the insulin is absorbed and how long it stays active.

This may be handy for people with Type 2 who use very large doses of insulin. However, it may not be easier on their wallets, since to keep people from giving themselves three times as much insulin as they need, Sanofi will only market Toujeo in pens, not the cheaper vials. The reason for this is that you would need to use a special U300 calibrated syringe to correctly dose U300 insulin. This would make possible terrible dosing mistakes, since someone accidentally using a syringe calibrated for U100 insulin with Toujeo would end up injecting three times as much Toujeo as they would need, a great way to cause a potentially fatal hypo. So to eliminate this possibility Toujeo will only be made available in pens calibrated to  dispense the expected dose.

If you are happy with Lantus, there is nothing to suggest that you need to switch to Toujeo. Though you can expect to see a heavy advertising campaign intended to make you think you should. Sanofi had hoped to market Toujeo in the U.S. with the claim that it caused fewer hypos than Lantus, but the FDA did not feel that the data they submitted proved this. So the only real selling proposition for Toujeo is that it makes dosing very large doses easier.

However, the European regulators did approve the claim that Toujeo caused fewer hypos than Lantus, so you can pretty much take your choice about who to believe. This kind of disagreement suggests to me that the difference in hypos between Lantus and Levemir is small enough that it could easily be due to the drug company tweaking the way it designed its comparison study and analyzed its data.

What About Tresiba?

If you are in Europe and want a more highly concentrated basal insulin, you can also get a pen version of Novo Nordisk's Tresiba that is U200, which allows you to inject 160 units in a single shot. Tresiba also comes in a U100 format.

Tresiba, unlike Toujeo is a truly new analog insulin  molecule, insulin degludec. Because it is new, and like all analog insulins is not quite identical to human insulin, its long term side effects have yet to be fully understood. This is why they F.D.A. has delayed approving it, out of concern that it might have a different profile in regard to cardiovascular effects.

The European label for Tresiba supports its claim to dramatically lower the incidence of nighttime hypos, which might be a strong selling point once it does get approved in the us.

People with diabetes have to hope that this injection of competition into the basal market will result in prices dropping to the benefit of consumers. But in the strange Alice in Wonderland world of Big Pharma this is far from guaranteed.  Worst case, some people fear, cheaper biosimilars that do not actually perform as well as branded basal insulins may be imposed on us by insurers who will treat them just like any other generic drug and refuse to pay the premium for a branded insulin if a biosimilar exists. If as some argue small chemical differences in these biosimilars keep them from actually duplicating the effect of the molecule they mimic, this could be a big problem going forward. Best case, some of the newer basals may perform better and insurers may cover them because they prevent those serious hypos. We'll know how it works out in another couple years.


13 comments:

Kimberly said...

Thanks for the great information.

David Dikeman said...

Great information. Thanks for doing what you do.

Ahmed Afifi said...

You always the best Jenny - Thanks for the info , just little questions is Toujeo can face the same of allegation that lantus faced earlier of possibility to cause cancer

Jenny said...

Ahmed, Further study appears to have disproven the claim that Lantus promotes cancer. I read through the related publications and was convinced.

The problem here is that people with Type 2 who needed Lantus were typically those who had been running very high blood sugars for many, many years before starting insulin. Since high blood sugars do promote cancer growth, it isn't surprising that the population taking the drug might have had a higher than normal rate. But the work they did seemed to rule out that it was the Lantus causing the cancers.

Dkat said...

Please be cautious with prescribing Toujeo. As an MD and a diabetic, the delayed onset of blood sugar control with extreme high and extreme lows alond with altered response to the U100 immediate acting insulin make this a niche product, not something for the well controlled diabetic on U100.

dejahthoris said...

@Dkat can you give me more info on why to be careful? Our endo gave some samples to my son and he has been using it a few days. He is type 1. It seems to make him run higher but now lows, so we are edging up his dose.

Taylor Ward said...

For type 1 or 2 diabetics seeking to lower their total insulin dosage to lose weight would this insulin be a sensible choice?

Jenny said...

Taylor,

There is the same amount of insulin in Toujeo as in the larger dose of Lantus, so it would have no effect on weight. All that is different is the volume of what the insulin is dissolved in.

I also don't believe that it is the amount of insulin that is making people gain weight. I think it is that most insulin isn't dosed properly, so people experience blood sugars that spike up and drop down in a way that increases hunger. If you get your insulin dose set properly so that your blood sugars stay flat, you should not feel hungry and can eat less. Doing this often requires that you use fast acting insulin to cover meals, since long acting insulins like Lantus and Toujeo can't stop spikes from happening after meals.

Marc said...

Jenny,
I'm a recently diagnosed type-2 diabetic, after a surprise episode of hyperglycemia with a BS @ 771. I now take Lantus every night. My BS stays between 80 and about 125, with occasional after meal readings as high as 152. I was under the impression that I was managing my BS quite well and have only gone above 160 twice in the past 6 weeks.
You mention that BS spikes may be a cause for weight gain (or in my case, maybe simply being unable to lose weight.) I was wondering if you could elaborate on what kind of spikes to which you were referring? I'd like to see if I'm correct that I'm not spiking since I'm staying in an acceptable range.
Thank you.

Jenny said...

Marc, You are doing extremely well. The kind of spikes I'm referring to are those where someone is spiking up to 250 or higher after a meal and then dropping back 100-150 mg/dl. Very few people with Type 2 have as tight control as you do.

I wouldn't worry about it with the numbers you are seeing.

Linda Estes said...

Morning bs is around 100. Take 14 units of humlog eat by2 or 3 hours my bs can be as high as 250 also on 48 units of lantus

Unknown said...

My doctor prescribed Toujeo to replace the Levimir that I have been taking for years. I was taking 80 units every morning of the Levimir. The dr. said for me to take the same amount of Toujeo. If Toujeo is u300 and Levimir is u100, how would it be possible to take the same amount without killing myself? What dosage should I take of Toujeo?

Jenny said...

Unknown,

The Toujeo pens are set up so the 80 unit marking on the pen dispenses the same 80 units of insulin as a Levemir pen would. All that is different is how much liquid that 80 units is dissolved in.

What dose did the doctor tell you to take? If he wasn't clear on this, you need to phone his office and check.

Toujeo lasts longer than Levemir does, so the same number of units might have a different impact on your blood sugar. Be sure to test throughout the day if you make the switch see how your blood sugar performs. If you fear you might be going low, call the doctor's office and discuss this with someone who is qualified to change your insulin dose. If you speak to a nurse, be sure they are an RN not an LPN who would not be trained to do this.