Shots:
- The CHMP’s positive opinion is based on P-III DISCOVER-1 & -2 studies assessing guselkumab (100 mg, q4w/q8w) vs PBO in 381 & 739 patients with active PsA & patients who were biologic-naïve only & who had an inadequate response to standard therapies respectively
- Combined results: @24wks. improvement in ACR (20%); improvements in quality of life scores SF36; higher PASI 75, PASI 90, and PASI 100 response rate were observed. In both studies, Tremfya was generally well tolerated through study completion
- Guselkumab is the first approved mAb that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. If approved, guselkumab will be the first selective (IL)-23 p19 subunit inhibitor licensed for both PsA and moderate to severe PsO
Click here to read full press release/ article | Ref: Janssen | Image: PMLive
The post Janssen’s Tremfya (guselkumab) Receives CHMP’s Positive Opinion for Approval to Treat Active Psoriatic Arthritis (PsA) first appeared on PharmaShots.
