Novo Nordisk gets positive news from Europe regarding insulin drugs

The products are Tresiba, an insulin degludec, and Ryzodeg, which combines insulin degludec and insulin aspart

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COPENHAGEN, Denmark—Novo Nordisk announced Oct.19 that the Committee for Medicinal Products for Human Use (CHMP) under theEuropean Medicines Agency (EMA) released positive opinions regarding marketingauthorizations for Tresiba and Ryzodeg for the treatment of diabetes mellitusin adults.
Tresiba, which is the intended brand name for the insulinproduct degludec, is what Novo Nordisk calls "a new generation of once-dailybasal insulin." In treat-to-target studies supporting the new drug application,where Tresiba was compared to insulin glargine, Tresiba demonstrated asignificantly lower risk of overall and nocturnal hypoglycaemia, whilesuccessfully achieving equivalent reductions in HbA1c, according to the company.Furthermore, with a duration of action beyond 42 hours, Tresiba is reportedly thefirst basal insulin to offer patients the possibility of adjusting the time ofinjection when needed.
For its part, Ryzodeg is the intended brand namefor the combination of insulin degludec and insulin aspart in a single compoundthat can be administered once or twice daily with the main meal or meals of theinsulin patient. In treat-to-target studies supporting the new drugapplication, where Ryzodeg was compared to NovoMix, Ryzodeg is said to have demonstrateda significantly lower risk of overall and nocturnal hypoglycemia whilesuccessfully achieving equivalent reductions in HbA1c. 
According to Novo Nordisk, Tresiba and Ryzodegwill be available in Europe in the FlexTouch, the company's latest prefilledinsulin pen, featuring what is intended to be an easy auto-injector mechanism.Tresiba will be offered in two concentrations enabling maximum doses of 80 and160 units per injection, respectively.
"We are very happy about the positive opinionsfrom the CHMP. This gives us confidence, that we soon can make Tresiba andRyzodeg available to many people with diabetes in Europe," said Mads KrogsgaardThomsen, executive vice president and chief science officer of Novo Nordisk.
Although the opinion from the CHMP isn't a surething, it suggests very strongly that the European Commission will ultimately grant approval through the EMA,and Novo Nordisk expects to receive final marketing authorization from the EuropeanCommission within approximately two months. Subject to the commission'sapproval and completion of pricing and reimbursement discussions, Novo Nordiskexpects to launch Tresiba in a number of European markets in the beginning of2013.
It will likely be about one year after that that Ryzodegwill see its own launch.
SOURCE: Novo Nordisk news release

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