Johnson & Johnson Seeks FDA Approval for Subcutaneous Tremfya in Ulcerative Colitis

Johnson & JohnsonView company profile has submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval of a subcutaneous (SC) induction regimen of TremfyaSearch drug (guselkumabSearch drug) for adult patients with moderately to severely active ulcerative colitisSearch disease (UC). This submission is based on positive findings from the Phase III ASTRO trial, highlighting the potential for Tremfya to offer a novel treatment option for this patient population.

The ASTRO trial (NCT05528510View clinical trial) evaluated the efficacy and safety of TremfyaSearch drug as SC induction therapy, administered at a dose of 400 mg at weeks zero, four, and eight. The study included adult patients with moderately to severely active UC who had an inadequate response or intolerance to conventional therapy, prior biologics, and/or ozanimod or approved JAK inhibitors. Patients were randomized to receive Tremfya 400 mg SC induction followed by either Tremfya 200 mg SC every four weeks (q4w) or Tremfya 100 mg SC every eight weeks (q8w), or placebo.

The primary endpoint of the ASTRO trial was clinical remission at week 12, which TremfyaSearch drug achieved with statistical significance and clinical meaningfulness using the 400 mg SC induction dose. The trial also met its secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement. Safety findings were consistent with prior data from the QUASAR program. Common adverse events associated with Tremfya include respiratory tract infections, injection site reactions, and arthralgia.

TremfyaSearch drug is a fully human, dual-acting monoclonal antibody that blocks interleukin (IL)-23 by binding to the p19 subunit of IL-23Search term and to CD64, a receptor on cells that produce IL-23. It is already approved for treating adult patients with moderate to severe plaque psoriasis, active psoriatic arthritis, and, most recently, moderately to severely active UC (approved in September 2024).

The FDA previously approved TremfyaSearch drug for UC based on the Phase II/III QUASAR trial (NCT04033445View clinical trial), which assessed its efficacy and safety in UC patients with inadequate response or intolerance to conventional therapy, prior biologics, and/or Janus kinase (JAK) inhibitors. The QUASAR trial demonstrated that 50% of patients receiving the 200 mg dose and 45% receiving the 100 mg dose of Tremfya achieved clinical remission by week 44, compared to 19% of patients on placebo.

Esi Lamousé-Smith, MD, PhD, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & JohnsonView company profile Innovative Medicine, stated, "With the ASTRO study in UC and the GRAVITI study in Crohn's disease, we are focused on delivering versatility and options for administration of treatment for people with inflammatory bowel disease (IBD). TremfyaSearch drug is the first IL-23Search term inhibitor to potentially offer a fully SC induction and maintenance regimen, which if approved, can provide choice and simplicity for patients and providers."

Full results from the ASTRO trial are expected to be presented at upcoming medical meetings.