Novo Nordisk’s insulin degludec injection, known by the brand name Tresiba, met with FDA approval in late September. It is expected to be available to patients with a doctor’s prescription in the first few months of 2016, according to Novo Nordisk’s chief medical officer for North America, Dr. Todd Hobbs.
“This insulin is very predictable and stable,” Hobbs says about Tresiba, which is a long-acting basal insulin. “It has a half life of 25 hours, and can last at least 42 hours.”
Hobbs points out while it’s advisable, and desirable, for diabetics to take their daily dose, or doses, of insulin at the same time each day, sometimes that simply isn’t possible. Sometimes, he says, life intrudes and a person is delayed in taking their medication. But, with Tresiba, such an occurrence wouldn’t necessarily impact blood sugar in a significant way.
“A patient might miss their dose by a few hours, but we designed Tresiba to accommodate those sorts of events,” he says.
Approval for Tresiba comes almost a decade after the molecule that forms the basis for the treatment was first isolated. Hobbs says that even before Novo filed its first attempt for approval through the FDA in 2012, Tresiba had already been in pre-clinical development for five or six years.
Tresiba is poised to be a direct competitor to the long-acting insulin, Lantus, which is sold by the pharmaceutical company Sanofi SA. Lantus is the market leader in long acting insulin with more than 80 percent of market share and annual sales of almost $8 billion. These figures, however, were before the patent on Lantus expired in Europe and the U.S. earlier this year.
Tresiba already boasts a commanding presence in the world insulin market. According to Science Times, Tresiba is sold in 30 countries around the world and is expected to generate more than $2 billion in annual sales within five years.
Novo Nordisk is set to launch Tresiba in the U.S. not as a direct replacement for Lantus (and for those making generic versions of the same formulation in the future) but as an improved choice. The first improvement over Lantus, according to Hobbs, is simply the length of time the insulin lasts.
Lantus lasts up to 24 hours per dose “with no pronounced peak,” according to information on the website Lantus.com, while Tresiba lasts considerably longer, according to Hobbs.
“We would not have brought this to market unless we thought it offered an advantage,” Hobs says. “The trial for Tresiba was the largest diabetic clinical trial ever conducted by Novo Nordisk,” he adds, noting that separate trials were conducted on type 1 and type 2 diabetics.
Hobbs says that more than 6,000 subjects were examined in trials associated with approval for Tresiba, and for another Novo Nordisk insulin formulation called Ryzodeg, which is a 70/30 percent combination of Tresiba and the short-acting insulin, Novolog.
Novo Nordisk cast a wide net in conducting these trials in part because in 2013 the FDA rejected Tresiba for approval, and asked for more studies to determine the level of cardiovascular risk from the drug. Those studies are still ongoing until sometime in 2016, but Novo Nordisk filed interim test results that led to FDA approval.
“One of the upsides of that was that all the data we had has been published and is available for examination and feedback,” Hobbs says.
Hobbs points out that there are some differences between how Lantus is administered and how Tresiba and Ryzodeg are administered. Neither of the new insulin formulations can be used in an insulin pump, Hobbs says.
Instead, Novo Nordisk developed a proprietary pen, FlexTouch®, that can deliver up to 160 units per dose. Additionally, the bulb of the pen does not extend outward as the number of units expends, which traditionally makes it more difficult to inject a dose. Hobbs says the pen was engineered so it was as physically easy to administer one unit of Tresiba as it would be to administer 160 units.
Hobbs says that he expects the majority of prescriptions for Tresiba and Ryzodeg to be written for type 2 diabetics.
“Basal insulin for type 2 diabetics is becoming a chief option for people interested in improved control over their diabetes,” he says.
While it remains to be seen how well Tresiba and Ryzodeg do in the U.S. insulin market, Hobbs is already satisfied with the product they’ve created.
“I’m very pleased,” he says. “I’m very happy the additional studies were needed because now we know how much better this is than the options that are on the market now.”