Novo Nordisk is celebrating after European regulators gave the green light to Tresiba and Ryzodeg, which the Danish company hopes will challenge Sanofi's Lantus, the world's biggest-selling insulin product.
The European Commission has granted marketing authorisations for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) for the treatment of diabetes in adults. Tresiba is a once-daily new-generation basal insulin analogue with an ultra-long duration of action.
The approval is based on studies supporting the new drug application where Tresiba was compared to Sanofi's blockbuster Lantus (insulin glargine) and demonstrated a significantly lower risk of overall and nocturnal hypoglycaemia, while successfully achieving equivalent reductions in HbA1c. Novo also claimed that with a duration of action beyond 42 hours, Tresiba "is the first basal insulin to offer patients the possibility of adjusting the time of injection, when needed".
Ryzodeg, which contains Tresida in a soluble formulation with Novo's NovoMix (insulin aspart) can be administered once or twice daily with main meal(s). Mads Krogsgaard Thomsen, Novo's chief scientific officer, said the approvals "constitute significant milestones" for the firm and the treatment of diabetes.
Novo expects to launch Tresiba in the UK and Denmark during the first half of 2013 and in other European markets thereafter. Ryzodeg is currently scheduled to be launched in a year's time.
Tresiba has been widely touted by analysts as a potential blockbuster. It has already been approved in Japan (as was Ryzodeq) and in November, the US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee voted 8-4 in favour of approving the two treatments.
The panel unanimously recommended that a cardiovascular outcomes trial should be conducted, but said this could be done post-approval.