The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a new dosing regimen for AbbVie's risankizumab (marketed as Skyrizi), issuing a green light for a single 150mg shot administered via pre-filled pen or pre-filled syringe every 12 weeks (following an initiation dose at week 0 and week 4).

The drug was originally approved as two 75mg subcutaneous injection doses, and so the MHRA’s decision will allow for reducing the number of injections per year by half. 

This move follows a green light from the European Commission based on data showing that the single risankizumab 150mg injection demonstrated bioequivalence to two injections of the risankizumab 75mg. In addition, the risankizumab 150mg pre-filled pen showed bioequivalence to the risankizumab 150mg prefilled syringe.

Belinda Byrne, AbbVie UK Medical Director, commented: “Since its approval, risankizumab has made an impact on the psoriasis treatment landscape, offering many people living with moderate to severe plaque psoriasis a meaningful treatment option. This approval marks a significant milestone in our ongoing pursuit to address the challenges people living with psoriasis experience, giving patients and their healthcare providers more options on their treatment journey." 

Risankizumab is part of a collaboration with Boehringer Ingelheim, with AbbVie leading development and commercialisation of of the drug globally. See SKYRIZI full summary of product characteristics (SmPC) at Globally, prescribing information varies; refer to the individual country product label for complete information.