FDA Approves Ultra-Long-Acting Basal Insulin Tresiba – Take It At Any Time of Day!

Twitter Summary: @US_FDA approves next-gen once-daily basal #insulin Tresiba, plus Xultophy (Victoza + Tresiba) now submitted

Novo Nordisk recently announced the FDA approval of the next-generation once-daily basal insulin Tresiba (insulin degludec) and the premixed insulin Ryzodeg (70/30 mixture of insulin degludec and insulin aspart). Tresiba will be launched in early 2016 and will come in prefilled FlexTouch pens. The insulin will launch in two concentrations (U100 or U200), enabling maximum doses of 80 units or 160 units per injection. Exact pricing information is unavailable at this time and we're really hoping that it's priced similarly to Levemir.

What makes Tresiba exciting? Several things:

• Flatter profile: Tresiba lowers blood sugar in a flatter, more predictable way than Levemir or Lantus.

• Less nighttime hypoglycemia: In certain trials, Tresiba seemed to cause less nighttime hypoglycemia vs. Lantus. This is not exactly “on the label,” but it seems to be true in the "real world” according to doctors with experience with Tresiba.

• Dosing Flexibility: Tresiba can be taken at any time throughout the day – for example, 8 am on Monday, 12 pm on Tuesday, and 7 am on Wednesday. The insulin lasts for an impressive 42 hours (at least), and doses must be taken at least eight hours apart. This flexibility is a major plus, as all other basal insulins (Levemir, Lantus, Toujeo) must be taken at the same time every day according to the label (though Toujeo gets reports in the real world of also having some further flexibility).

• Fewer Injections for those using high doses of insulin: Patients can take up to 160 units of Tresiba in a single injection with the U200 pen, which means most patients should be able to take a day’s worth of insulin in a single dose. Toujeo is like this too, and it’s a major advantage overall for next-generation basal insulins. 

Another exciting result of Tresiba’s approval is that Xultophy (which combines Tresiba with the GLP-1 agonist Victoza into a single injection and is also known as IDegLira) has now officially been submitted for FDA approval. While Xultophy is already approved in Europe for type 2 diabetes (yes, the US is behind again), it underwent a massive delay due to the Tresiba FDA issues, which are now resolved. 

Why is this so important? This new category of insulin/GLP-1 combination drugs could be a gamechanger for type 2 diabetes. In a major clinical trial comparing Xultophy to Lantus, Xultophy lowered A1c, weight, and nocturnal hypoglycemia more effectively than Lantus without significant side effects: more than five times as many patients on Xultophy as on Lantus achieved an A1c below 7% without hypoglycemia or weight gain.

Dr. Bruce Bode, who was involved in Tresiba’s clinical trials, enthusiastically reacted to the Tresiba approval and summed up the news succinctly: “This is fantastic news to patients with diabetes. Tresiba is a flat, long-acting predictable basal insulin with significant reduction in nocturnal hypoglycemia and the ability to take it anytime of the day. Ryzodeg is insulin degludec with insulin aspart - it controls glycemic excursions post-meal, as well as fasting glucose, but with a significant decrease in overall hypoglycemia compared to analog premixed insulins. The approval of degludec allows the submission of IDegLira [Xultophy], which is a gamechanger in the type 2 space, getting the majority of patients under a 7% A1c with minimal hypoglycemia and weight gain and GI side effects.” Thank you Dr. Bode! -AJW/ER

Photo Credit: media.tresiba.com