IQWiG does not recommend Tresiba (insulin degludec)for use in children with diabetes- Novo Nordisk

June 2015-The German Institute for Quality and Efficiency in Health Care (IQWiG) reviewed Tresiba (insulin degludec) both on its own and/or combination with other blood-glucose lowering drugs � but saw no added benefit. The licence under review for Tresiba is for adolescents and children with type I and type II diabetes. The IQWiG noted that Novo did not present any specific data for type II diabetes and therefore it could not make a decision on whether this was better than a comparator drug. The IQWiG stated that not only is there no added benefit when compared to other medicines, in girls, there is in fact a suggestion of greater harm regarding serious adverse events. The Institute found that within 52 weeks, severe side effects occurred in around 15 of 100 girls who received Tresiba. In girls who received standard treatment, this was the case in only around three of 100 girls.The German GBA will make a final decision on the pricing of the drug.

Comment: The drug has EU approval for treatment of diabetes mellitus in adults, adolescents and children from the age of 1 year.

Comment: In the US, Novo Nordisk has re submitted to the FDA an interim analysis from the ongoing cardiovascular outcomes DEVOTE trial as well as pharmacovigilance data from use of Tresiba outside the US to support the applications for Tresiba and the combination version of the drug which is Ryzodeg (insulin degludec plus insulin aspart) .