EMEA expands label on Novo Nordisk's NovoMix 30

Danish health care firm Novo Nordisk says that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for a change in dosing guidelines for its premixed insulin analog NovoMix 30 (biphasic insulin aspart).

Once adopted, the new guidelines will enable patients currently-failing to control glucose levels on oral medication to start insulin therapy with a once-daily dose of NovoMix 30. In addition, subsequent intensification of insulin treatment to twice-daily dosing will be easier, using the same delivery device, the FlexPen. The extension of the current label is based primarily on the dosing regimen of the INITIATE study.