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  • JnJ seeks USFDA...

JnJ seeks USFDA approval for subcutaneous induction regimen of Tremfya in ulcerative colitis

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-11-29T11:30:21+05:30  |  Updated On 29 Nov 2024 11:30 AM IST
JnJ to resume US VARIPULSE cases
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Spring House: Johnson & Johnson has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a subcutaneous (SC) induction regimen of TREMFYA (guselkumab) for the treatment of adults with moderately to severely active UC. The filing is supported by data from the Phase 3 ASTRO study of TREMFYA SC induction therapy in adults with UC and builds upon the recent U.S. approval of TREMFYA in this indication.

The Phase 3 ASTRO study met its primary endpoint, achieving a statistically significant and clinically meaningful results or clinical remission at Week 12 with a 400 mg SC induction dose of TREMFYA administered at Weeks 0, 4, and 8. All secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI), were also met. Safety data from ASTRO were consistent with the safety findings from the QUASAR program. Results from the ASTRO study are planned for presentation at upcoming medical meetings.

“With the ASTRO study in UC and the GRAVITI study in Crohn’s disease (CD), we are focused on delivering versatility and options for administration of treatment for people with inflammatory bowel disease (IBD). TREMFYA is the first IL-23 inhibitor to potentially offer a fully SC induction and maintenance regimen, which if approved, can provide choice and simplicity for patients and providers,” stated Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. “The ASTRO results add to the compelling data generated from the QUASAR program in UC and build on the promise of TREMFYA in the treatment of IBD as we look to transform outcomes for patients.”

TREMFYA is an approved dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC.

TREMFYA received U.S. FDA approval in September 2024 for the treatment of adult patients with moderately to severely active UC and is currently administered via an IV induction regimen, followed by a SC maintenance regimen. The approval was supported by data from the Phase 3 QUASAR study evaluating the efficacy and safety of TREMFYA in adults with moderately to severely active UC.

An application seeking approval of TREMFYA for the treatment of adults with moderately to severely active CD has been submitted in the U.S., and applications seeking approval for both CD and UC have been submitted in Europe.

johnson and johnsonjohnson and johnson newsusfdatremfyaguselkumabulcerative colitis
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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