Johnson & Johnson (J&J) has submitted a supplemental biologics licence application to the US Food and Drug Administration for Tremfya (guselkumab), to treat ulcerative colitis (UC). 

Tremfya, a human immunoglobulin monoclonal antibody (mAb) blocks IL-23, a cytokine known to be a driver of immune-mediated diseases such as UC. Developed using HuCAL (human combinatorial antibody library) technology, the drug is already approved for plaque psoriasis and active psoriatic arthritis. 

The company’s submission follows positive results from the Phase III QUASAR (NCT04033445) clinical programme, showing that 22.6% of treated patients achieved symptomatic remission compared to 12.9% of the subjects in the placebo group after four weeks of treatment. The 701-subject cohort included UC patients who previously had an inadequate response or intolerance to conventional and/or advanced therapies.  

The UC drug landscape has seen several developments in the last few years, with one being an increase in the number of biosimilars for AbbVie’s Humira — a blockbuster drug indicated for UC, as well as other inflammatory conditions — coming through the market. Despite this, experts have said that there is a need for more efficacious drugs.  

Combination therapies have been investigated to tackle this, with Tremfya featuring in a Phase II VEGA trial (NCT03662542), along with the approved UC drug Simponi (golimumab), in UC patients. The reported remission rate in patients treated with Tremfya monotherapy in the trial was 31%, compared to the combined regimen which increased the remission rate to 47.9%.  

Tremfya generated $3.1bn in 2023, as per J&J’s annual report. GlobalData forecasts the therapy to maintain its upward trajectory and generate $6.5bn in 2030, aided by an anticipated label expansion. 

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In the announcement accompanying the application, J&J global immunology therapeutic area head David Lee said: “Tremfya has the potential to be a new treatment option for patients. We look forward to working with the FDA in a review of this application and remain focused on developing new therapies for those living with chronic autoimmune conditions, such as ulcerative colitis, who are experiencing persistent and debilitating symptoms.” 

It’s been a busy week for the pharma giant, following the completion of its acquisition of the clinical-stage company Ambrx Biopharma in a $2bn deal to enhance its oncology portfolio on 8 March.