Janssen's IL-23 Inhibitor Guselkumab Nominated for Priority Review in China for Crohn's Disease

▎WuXi AppTec Content Team Report

Today (March 6), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that Johnson & Johnson Innovative Medicine, a subsidiary of Johnson & Johnson,AppliedGuselkumab Injection Proposed for Priority ReviewApplicable toTreatmentAdult patients with moderate to severe active Crohn's disease. Public data show that Guselkumab is aInterleukin (IL)-23 Inhibitor`, which has previously been approved in China for the treatment of psoriasis.`

Screenshot source:CDE Official Website

GuselkumabIt is a specific anti-IL-23 monoclonal antibody,By binding to the p19 subunit of IL-23, it blocks the action of IL-23.。IL-23 is a cytokine associated with inflammation, and the IL-23 pathway is considered to be related to many chronic immune diseases.GuselkumabPreviously approved in the United States for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, etc. In 2019, Guselkumab was approved in China for adult patients with moderate to severe plaque psoriasis suitable for systemic therapy.

This timeGuselkumab is proposed for inclusion in the priority review, targeting the indication ofCrohn's Disease. It is a chronic systemic disease characterized by inflammation in the gastrointestinal or digestive tract, which can cause persistent diarrhea, abdominal pain, and rectal bleeding during flare-ups.It is a progressive disease that worsens over time.Due to the unpredictable symptoms of Crohn's disease, it imposes multiple burdens on patients physically, emotionally, and financially. For the indication of Crohn's disease,Guselkumab has previously been included in the breakthrough therapy category by the CDE.

GuselkumabPreviously in the Phase 2 GALAXI 1 study targeting moderate to severe Crohn's diseaseAchieve positive results。This Phase 2 clinical trial enrolled Crohn's disease patients who had an inadequate response or were intolerant to conventional therapies or biologics.The test results showed that subjects receiving different dosesAncientSesilimabIn the treated patient group,47.5%~66.7% of patients achieved a clinical-biomarker response(Defined as a clinical response and a 50% reduction in C-reactive protein or fecal calprotectin levels from baseline). In addition,The proportion of patients achieving endoscopic remission44.3%~46%Between; the proportion of patients who achieved clinical remission and normalization of C-reactive protein or fecal calprotectin levels39.3~66.7%Between.

Researchers believe that, compared with placebo,GuselkumabAll three dosing regimens induced greater clinical and endoscopic improvements with a favorable safety profile.