Armed with new clinical data, Novo Nordisk intends to resubmit its marketing applications for diabetes therapies Tresiba and Ryzodeg to the FDA, after being turned down two years ago.
The US regulator rejected its marketing application for basal insulin product Tresiba (insulin degludec) and combination therapy Ryzodeg (insulin degludec and insulin aspart) in February 2013, despite a vote in favour of approval of the two drugs by its own advisory committee the previous November.
The FDA said at the time it turned down the two drugs because it wanted additional proof of the products’ safety from a cardiovascular outcomes trial, setting back Novo Nordisk’s plan to mount an assault on Sanofi’s $8bn-a-year blockbuster Lantus (insulin glargine) by at least two years.
The decision also cast a shadow over the US development of Xultophy, a combination of insulin degludec and the active ingredient in Novo Nordisk’s Victoza (liraglutide) that recently debuted in Switzerland.
Now, the Danish pharma company says it has interim data from an ongoing cardiovascular outcomes study called DEVOTE that will allow it to press ahead with a resubmission of its marketing applications for both Tresiba and Ryzodeg “within the next month,” keeping it on course for a possible launch in the US next year.
DEVOTE was started in October 2013 and is comparing the safety of insulin degludec with insulin glargine in more than 7,600 patients with type 2 diabetes – aged over 50 and at high risk of cardiovascular events – with final data due in November 2018 according to the listing for the trial on clinicaltrials.gov.
The news is a massive boost for Novo Nordisk and its investors as the company had confirmed earlier this year it would either file on the basis of the interim analysis or would have to wait until the final study results.
The DEVOTE data is one just part of the resubmission, according to Novo Nordisk, and the company will also file pharmacovigilance data from use of the drug outside the US, which will include experience with more than 100,000 patients and a similar number in Europe.
Tresiba was first launched in Japan in March 2013 and has captured more than a quarter of the basal insulin market there, according to Novo Nordisk’s chief executive Lars Rebien Sørensen. The drug is now available in more than 20 markets outside the US.
“We are not seeing any signs or signals neither in the pharmacovigilance systems … that has changed our clear view that Tresiba is safe as other insulins,” said Sørensen ahead of the DEVOTE analysis.
The company has always maintained that insulin degludec has a very long and predictable pharmacological action profile – meaning it can be delivered at any time of day – as well as a lower tendency to cause low blood sugar (hypoglycaemia) than Lantus.