Janssen adds to body of guselkumab evidence ahead of EC decision

With a European Commission (EC) decision due by the end of this year on whether to approve guselkumab as a treatment of moderate to severe plaque psoriasis, Janssen cannot have harmed its chances of a positive outcome by presenting impressive new longer-term data.

The biotech unit of healthcare giant Johnson & Johnson (NYSE: JNJ) has shown, in the open-label extension of the Phase III VOYAGE 1 trial, consistent rates of skin clearance with guselkumab treatment through week 100 among patients receiving the subcutaneously administered anti-interleukin (IL)-23 monoclonal antibody.

If approved, guselkumab will be marketed under the name Tremfya. It is already approved in the USA and last week received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use, meaning approval is likely within the next two months.