Let's face it, we all appreciate the insulin that keeps us alive, but wish it worked more effectively and was easier to dose. Novo Nordisk's latest innovation, new ultra long-lasting Tresiba basal insulin, is potentially huge news for people with diabetes (PWDs) because it offers options on when and how we take our insulin. It actually has the potential to last for nearly two days between doses (!).
On Sept. 25, the New Jersey-based Pharma giant received word from the FDA that it had the green light to begin selling Tresiba insulin in the U.S. Known in official medical lingo as "insulin degludec" but sold under brand name Tresiba (pronounced Tra-seeba), the product is already available in 30 countries around the globe, and will begin shipping here in the States in late 2015 or early 2016.
On the same day, the FDA also approved Novo's secondary 70/30 insulin mix known as Ryzodeg, which is a combo of 70% Tresiba basal and 30% rapid-acting NovoLog insulin. That means you can take this insulin mix with a meal, and get both the short- and long-term effects of these Novo insulins.
These approvals are a big milestone for Novo, coming two years after the FDA first shot down Tresiba approval based on concerns over cardiovascular risks; the company conducted a number of additional clinical studies since and submitted the new data earlier this year.
Although it's ideal practice, most of us patients find it next to impossible to take our insulin at the exact same time every single day. So with Tresiba's long-lasting effectiveness and the combo Ryzodeg adding in a meal-time insulin, we get much more flexibility for successful dosing.
What's Really Different About Tresiba?
What's new about Tresiba is that it is actually a long-lasting basal insulin. It stays effective for 42 hours between doses, meaning it offers patients the flexibility to take some injections every other day, if they need to. Granted, Novo recommends that patients take it daily and that's what the FDA's approved it for, but with that 42-hour effectiveness it offers flexibility unprecedented by other background insulins.
So let's say you take one Tresiba dose on Monday at 9 a.m. You could theoretically wait to take the next dose until Tuesday at 5 p.m., and you might want to take Ryzodeg instead with dinner before you take the next dose of Tresiba on Wednesday morning at 9 a.m. again. Go, flexibility!
Another unique aspect of this new Tresiba is that it's available in both U100 and U200 concentrations. In the U100 pen, you can give a max of 80 units for a single dose, while in the U200 pen, you can give a maximum single dose of 160 units. That's way more than any competitors offer, and a big benefit for anyone with T2 who needs large amounts of insulin.
Apparently, Tresiba can also last longer outside the refrigerator compared to other insulins of its kind. It holds up for as long as 8 weeks at room temperature before losing its potency. This means you'll be less likely to waste any by having to throw a pen out after the typical 28 days of life for other insulins. Nice!
The new Tresiba FlexTouch pen actually seems pretty cool all on its own -- but has been downplayed thanks to all the media buzz on the insulin itself. In addition to being able to dose higher amounts than current pens, you can do so without any button extension or extra force required than needed for a 10-unit dose. So it's hand-friendly, so to speak.
A Talk with Novo's Chief Medical Officer Todd Hobbs
While looking into Tresiba, we connected with Novo's Chief Medical Officer Dr. Todd Hobbs, who's also a longtime type 1 himself. Todd has been making the rounds in the DOC (Diabetes Online Community) of late with some great interviews earlier this year here and here. Todd was diagnosed in college and also has an 11-year-old son named Carter who was diagnosed at age 5. Todd has six boys in total (!), but the father-son pair are the only two in the family with T1D.
Todd says he and his wife had all six kids tested for antibodies, but only Carter ended up developing T1D six years ago. When he clocked in at 300 blood sugar, Todd gave his son his first dose of Levemir.
“We didn’t freak out when he was diagnosed, and I think that positive attitude helped him accept and live with it, and to have such a positive attitude about diabetes himself. He’s seen me doing this his whole life, so he knows what he has to do.”
Todd tells us that he'd always planned to be a physician, but getting diabetes himself solidified that plan. He worked for years in a diabetes specialty practice, but mounting family and financial challenges pushed him toward taking a field medical position with Novo Nordisk in 2004. From there, he's moved up the ranks to roles such as Head of Insulin for North America. And in 2014, he became Novo's Chief Medical Officer for North America.
Todd laughs when realizing that truly, he's only ever used Novo insulin since becoming dependent on the stuff; he started on Novo's first-ever 70/30 pen back in the 90s. He and his son are now both using the Animas Vibe pump with CGM.
Of course, we had to ask Todd if he has any "early access" to new products being made at Novo. He says he doesn't use anything before it's actually approved by the FDA, but he does get first crack at trying things out once they're approved. He now has some Tresiba on hand as a backup to his pump, for example.
That brought up the issue of access to these diabetes medications...
Access to Insulin and Diabetes Medication
Todd tells us Novo is keenly aware of the controversy around the high cost of insulin, and it goes without saying that he personally 'gets it,' as he has to pay for insulin himself like the rest of us.
That said, Todd tells us the Tresiba "list price" will be a higher premium than existing Novo insulins. But that doesn't matter much, since many don't pay the list price but rather some portion determined by their insurance, so it comes down to formulary lists and insurance rates.
That's why he's pushed Novo to promote co-pay patient assistance programs as a way to help more people access insulin. Since the Affordable Care Act requires everyone have insurance now, Todd says Novo is doing what it can to help keep co-pays as close to $15 as possible.
"For those patients who fall through the cracks and maybe don't have the best insurance, we're going to push this co-pay assistance and help them as much as we can so their co-pays aren't as high," he says. "There will also be samples and other things offered, but (the co-pay program) is the main issue."
The Insulin Wars and Future Pipeline
This newest insulin approval seems to give Novo an edge over Sanofi, Lilly and others in the diabetes med market. They now have a first-of-its-kind ultra long-acting basal insulin, and they tell us more innovations are on the way.
We patients have been waiting for a long time for an insulin that starts kicking in quicker than the current NovoLog, Humalog and Aprida. Of course we now have Afrezza inhaled insulin available for mealtimes, which many are finding extremely effective.
Now, a faster-acting version of NovoLog could be ready sometime in 2016, if all goes as the company plans. Yes, Novo is finishing up Phase III clinical studies on the improved version and hopes to submit that data to FDA by the end of this year. No brand name yet for what is now called NN11218, as that doesn't happen until everything's filed with the FDA, and different names are presented as options. For now, we're just happy to refer to it as "The Faster Next-Gen NovoLog!"
"We know that even just a few minutes makes a difference when you're taking insulin and trying to stop post-prandial spikes," Todd says. "Right now, it's too early to say how quickly this will actually work but we know it will be much faster than what we have now."
We're also excited to hear some hope for injectable GLP-1 drug Victoza, which data showed earlier this year wasn't exactly the best option for people with type 1. But Todd tells us that door isn't closed yet.
"We are still analyzing that," Todd says. "As a type 1, the use is very individualized. Translating that to a large-scale clinical trial and treatment plan is very challenging and there are more stringent guidelines. What the data and news showed recently is that we wouldn't be pursuing this FDA approval for right now, but we're not walking away and will look at that in other ways in the future."
Lots of exciting stuff on tap for new treatment options for us PWDs, though clearly it all comes down in the end to affordability and access. Keep em coming, Novo, but please do something about making sure all PWDs have access to your insulin and diabetes products.