Shots:

• The sBLA is based on two P-III DISCOVER-1 & 2 studies assessing Tremfya (SC) in 381 & 739 patients with active PsA including prior treated patients with anti-TNF therapy and continued through 52wks. & biologic-naïve patients planning to continue through 100wks. respectively
• The P-III DISCOVER-1 & 2 studies resulted in meeting their 1EPs i.e- ACR20 @24wks.- the safety profile is consistent with prior studies
• Tremfya (guselkumab) is a mAb targeting p19 subunit of IL-23 and is the first approved selective IL-23 inhibitor- received the FDA’s approval for mod. to sev. plaque psoriasis in July’2017 with its anticipated MAA submission to EMA for PsA in H2’19

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Ref: Johnson & Johnson | Image: Janssen