Janssen’s Tremfya (guselkumab) Receives FDA’s Approval for Moderate-to-Severe Plaque Psoriasis in Adults

Shots:

• The approval is based on P-III study results assessing Tremfya (guselkumab, 100mg) vs PBO in 78 patients with moderate-to-severe plaque psoriasis
• P-III ORION study: IGA score of 0/1 or PASI 90 @16wks. (81%, 76% vs 0%,0%); IGA score of 0 @16 wk (56% vs 0%); PASI 100 response @16 wks (50% vs 0%)
• Tremfya (guselkumab,100mg, SC) is a mAb offering one-press patient-controlled injector inhibiting interleukin (IL)-23, evaluated in two P-III trials for active psoriatic arthritis & Crohn’s disease and is approved in the US, EU, Canada & Japan for moderate-to-severe plaque psoriasis in adults

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