Janssen Reports Submission of sBLA to the US FDA for Tremfya (guselkumab) to Treat Active Psoriatic Arthritis
Janssen Expands Clinical Development for Tremfya(R) (guselkumab) in Familial Adenomatous Polyposis (FAP)
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
Click here to read full press release/ article | Ref: Johnson & Johnson | Image: Behance