Novo Nordisk’s Tresiba (insulin degludec injection) has been approved in the US and is the first new FDA-approved basal insulin molecule in 10 years.
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In a separate action, Novo Nordisk announced that an NDA for Xultophy, the first once-daily single-injection combination of Tresiba and liraglutide (Victoza, Novo Nordisk), has been submitted to the FDA. Novo Nordisk is the world’s No. 1 maker of insulin, a hormone normally produced by the pancreas that helps the body use glucose for energy. Novo Nordisk shares are heading in the right direction of their best day in six months. To preserve the integrity of the ongoing DEVOTE trial, only a small, dedicated team within Novo Nordisk has access to the data.
Tresiba is already sold in 30 countries, and analysts expect annual sales of $2.4 billion by 2020, according to Thomson Reuters Cortellis.
With a launch in the USA now expected in the first quarter of 2016, the Danish company has a chance to get the franchise back on course, although it will have a tougher time now than it would have done in 2013. Todd Hobbs, chief medical officer for Novo Nordisk in North America, said diabetics using Tresiba can go as long as 42 hours between doses, compared with 18 to 24 hours for Levemir, the company’s current long-lasting insulin. A company spokesman said a launch target for Ryzodeg has not yet been determined.
Results of the trials showed that Tresiba and Ryzodeg, given to patients who had inadequate blood sugar control at trial entry, reduced hemoglobin A1C (HbA1c) similarly to reductions achieved with previously approved long-acting insulins and long-acting or pre-mixed insulins, respectively.
The FDA’s approval came after two years of the drug’s rejection.
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Novo Nordisk will be breathing a huge sigh of relief after United States regulators finally opened the door to its re-filed diabetes drugs Tresiba and Ryzodeg.
