Guselkumab injector for psoriasis in US

May 8, 2019 0 By FM

Guselkumab (Tremfya), a single-dose, patient-controlled injector, has been approved for adults with moderate-to-severe plaque psoriasis by US FDA.

Guselkumab is a human anti-IL-23 monoclonal antibody developed by Janssen utilizing MorphoSys’s proprietary HuCAL antibody technology.

In phase 3, multicentre and randomized ORION study, patient experience with the one-press injector was assessed through a validated Self-Injection Assessment Questionnaire (SIAQ), which evaluated patient experience.

The efficacy and safety of guselkumab administered with one-press in patients with moderate to severe plaque psoriasis were also evaluated in the double-blind, placebo-controlled ORION study.