The European Commission today granted Novo Nordisk approval across all 27 European Union member states for two new adult diabetes drugs—Tresiba® ( insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart).
Novo Nordisk said in a statement it expects to launch Tresiba in the U.K. and Denmark during the first half of this year, and in other European markets throughout the rest of 2013 and 2014. Ryzodeg is expected to be launched about one year after Tresiba rings up its first sales.
Both drugs will be available across Europe in Novo Nordisk’s new FlexTouch® prefilled insulin pen, which has an auto-injector mechanism. Tresiba will be offered in two concentrations enabling maximum doses of 80 and 160 units per injection.
The approvals come nearly a month after Japan granted marketing authorization to Ryzodeg on Dec. 25; Tresiba is already marketed there now.
In the U.S., FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Nov. 8 recommended approval of Tresiba and Ryzodeg, with a unanimous 12–0 stipulation that Novo Nordisk examine the cardiovascular safety of the drugs through a post-marketing outcomes trial. The company has estimated the cost of the additional study at DKK 1.5 billion (about $267.4 million). However, the panel split 8–4 on whether sufficient efficacy and safety data had been provided to support marketing of the products.
Tresiba and Ryzodeg are two key components in Novo Nordisk’s plans for a beachhead in the long-acting basal insulin segment of the diabetes drug market. The segment is now dominated by Sanofi, whose Lantus (insulin glargine) has grown to a market share estimated at 80% and blockbuster-level annual sales—€3.916 billion ($5.2 billion) in 2011 and almost as much, €3.625 billion ($4.8 billion), in the first three quarters of 2012. Sanofi will release fourth-quarter and full-year 2012 results on Feb. 7.
According to Novo Nordisk, Tresiba has a duration of action beyond 42 hours, making it the first basal insulin to offer patients the possibility of adjusting their time of injection. Ryzodeg can be administered once or twice daily with the main meal(s).
Both drugs were approved following treat-to-target studies that concluded the Novo Nordisk diabetes treatments outperformed drugs already on the market. Tresiba showed significantly lower risk of overall and nocturnal hypoglycemia compared with Lantus, while successfully achieving equivalent reductions in HbA1c. And compared with Novo Nordisk’s NovoMix (biphasic insulin aspart), Ryzodeg also demonstrated a significantly lower risk of overall and nocturnal hypoglycemia, while successfully achieving equivalent reductions in HbA1c.