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.
免責聲明:投資有風險,本文並非投資建議,以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請,作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考,不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證,投資者應自行研究並在投資前尋求專業建議。