Tresiba and Ryzodeq Approved by EU Regulators
European regulators have approved Novo Nordisk’s Tresiba and Ryzodeg, which Novo hopes will challenge Sanofi’s Lantus, the largest selling insulin product globally.
The European Commission have granted marketing authorisations for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) for the treatment of diabetes in adults.
The green light was founded on clinical trials conducted where Tresiba was compared to Sanofi’s blockbuster Lantus, and showed a considerably lower risk of overall and nocturnal hypoglycaemia, while successfully achieving equivalent reductions in HbA1c.
Tresiba is a once-daily new-generation basal insulin analogue with an ultra-long duration of action. Novo Nordisk stated 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 the company’s NovoMix (insulin aspart) can be administered once or twice daily with main meal(s). Novo’s chief scientific officer, Mads Krogsgaard Thomsen, noted the approvals “constitute significant milestones” for both the organisation and the treatment of diabetes.
The company anticipates launching 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 hyped by analysts as a potential blockbuster. It has already been approved in Japan, and in November 2012, the US FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 8-4 in favour of approving the two diabetes drugs.
The panel recommended that a cardiovascular outcomes trial should be conducted, but added that this could be done post-approval.