Janssen Reports Submission of sBLA to the US FDA for Tremfya (guselkumab) to Treat Active Psoriatic Arthritis

 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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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