Janssen’s Tremfya (guselkumab) Receives the US FDA’s Approval as the First Selective IL-23 Inhibitor for Active Psoriatic Arthritis

Shots:

• The approval is based on two pivotal P-III clinical trials (DISCOVER-1 and DISCOVER-2) assessing Tremfya (100 mg, SC, q8w) following two starter doses @0 & 4wks. vs PBO in 1,120 adults with active PsA who had an inadequate response to standard therapies. Tremfya is the 1st and only biologic approved for PsA to improve fatigue as measured by FACIT-F in the product label
• Results: DISCOVER-1 & 2 study, ACR20 (52% & 64% vs 22% & 33%), in pooled analysis @24wks., resolved enthesitis (50% vs 29%), resolved dactylitis (59% vs 42%) respectively.  Additionally, it improved signs and symptoms in joints, skin, and soft tissue in adults with active PsA
• Tremfya is the 1st approved fully human mAb that targets IL-23. It is approved in the US, Canada, EU, Japan, and other countries globally for moderate to severe PsO & in the US, Japan, and Brazil for PsA

Click here ­to­ read full press release/ article | Ref: Janssen | Image: MPR