EMA advisors recommend approval of once-daily at unique higher strength
Novo Nordisk's Tresiba (insulin degludec) has been recommended for approval in Europe, putting it on course to become the first higher-strength insulin licensed in the region.
The CHMP backed the once-daily basal analogue insulin's use as a treatment of diabetes mellitus in adults at both 100 units/ml and 200 units/ml strengths.
For many years the standard dose in the EU has been 100 units/ml and the CHMP said the approval of Tresiba's higher strength dose is “expected to respond to the growing need for higher-dose insulin”.
It is estimated that between 200,000 and 700,000 diabetes patients in the EU require insulin injections of more than 80 units per injection, the maximum dose that can be given with a single injection of a 100 units/ml product. Tresiba as a 200 units/ml insulin would allow doses up to 160 units in a single injection.
The CHMP also recommended Novo's Ryzodeg (insulin degludec/insulin aspart) combination, which contains insulin degludec in a formulation with a bolus boost of Novo's NovoRapid (NovoLog in the US) to provide further glucose control.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said: “We are very happy about the positive opinions from the CHMP. This gives us confidence, that we soon can make Tresiba and Ryzodeg available to many people with diabetes in Europe.”
If, as is usually the case, the CHMP's positive opinion on Tresiba translates into full EU approval within three months, it would give the insulin a boost in its quest to rival Sanofi's blockbuster Lantus (insulin glargine).
In trials supporting its European submission, Tresiba was compared to Lantus and Novo said it demonstrated a significantly lower risk of overall and nocturnal hypoglycaemia, while successfully achieving equivalent reductions in HbA1c.
European approval for the two insulins could also help ease the effects of US delays, after the FDA decided it wanted clarification and further analyses for the data submitted on Tresiba and Ryzodeg, pushing its decision date back to the end of this month.
European approval of Tresiba, which was submitted to Japanese regulators earlier this year, will require Novo to take steps to counter the risk of the wrong dose being used.
These include only offering the 200 units/ml strength in a pre-filled pen, with a clearly differentiated pack design from the lower dose and running an educational programme about the product.
Novo Nordisk said it expects to launch Tresiba in a number of European markets in early 2013, with Ryzodeg due to hit these markets about a year later.