4 June 2021 - Approval based on results showing the new formulation of risankizumab 150 mg demonstrated bioequivalence to two injections of risankizumab 75 mg.
AbbVie today announced the MHRA has approved a new risankizumab 150 mg presentation, to be administered by one injection per dose via pre-filled pen or pre-filled syringe every 12 weeks following an initiation dose at week 0 and week 4.
Originally approved to be administered by two 75 mg subcutaneous injection doses, this additional approval reduces the number of injections per year by half for the same therapeutic amount per dose as the two 75 mg dosing.