Johnson & Johnson Submits sBLA to FDA for TREMFYA® Label Update to Include Inhibition of Joint Damage in Psoriatic Arthritis

Reuters
29 Jul
Johnson & Johnson Submits sBLA to FDA for TREMFYA® Label Update to Include Inhibition of Joint Damage in Psoriatic Arthritis

Johnson & Johnson has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to include new evidence in the label of TREMFYA® (guselkumab) for adults with active psoriatic arthritis. This submission is based on 24-week results from the Phase 3b APEX study, which demonstrated significant inhibition of joint structural damage, making TREMFYA® the only IL-23 inhibitor to provide such benefits. The study achieved its primary and major secondary endpoints, showcasing TREMFYA®'s effectiveness in symptom control and joint damage inhibition in bio-naïve patients. The data from this study align with TREMFYA®'s well-established safety profile, and further information will be shared at upcoming medical meetings.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Johnson & Johnson published the original content used to generate this news brief via PR Newswire (Ref. ID: NY39300) on July 29, 2025, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10