USA approves Novo’s long-acting insulins

Shares in Novo Nordisk rose as much as 5 percent on Monday after the U.S. Food and Drug Administration (FDA) approved the diabetes drug Tresiba, allowing the Danish drugmaker to prepare its largest ever drug launch.

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.

Tresiba is already made available in 30 countries, and analysts are looking forward to annual sales of $2.4 billion by 2020, as reported by Thomson Reuters Cortellis. () U.S.-listed shares of Novo Nordisk fell 10 cents to close at $54.93 on Friday.

But the USA market approval is unequivocally positive news for Novo, which has been chasing another direct competitor for Sanofi’s flagship Lantus for years.

The approved drugs are Treiba and Ryzodg 70/30, both treatments for adult diabetes. 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. “We want to do everything we can to make it as affordable and as broad of an access as we can”, Hobbs said.

On March 26, 2015, Novo Nordisk announced the decision to submit the class II resubmissions of the NDAs following the completion of the interim analysis of the cardiovascular outcomes trial for insulin degludec, DEVOTE. According to Novo, it is the first basal insulin to offer patients the possibility of injecting at any time of the day with the option to adjust timings, and a United States launch is scheduled for the first quarter of next year. “The approvals mark an important milestone for Novo Nordisk“.