By Fineline Cube 
US giant Johnson & Johnson (J&J; NYSE: JNJ) announced that it has received regulatory approval from the European Commission (EC) for its Tremfya (guselkumab) to treat adult patients with moderately to severely active ulcerative colitis (UC). The approval applies to patients who have had an inadequate response, lost response, or were intolerant to conventional therapy or a biologic treatment.
Clinical Trial Results
The EC’s approval is supported by positive results from the QUASAR program, which includes Phase IIb induction dose-ranging and Phase III induction and maintenance studies. In the QUASAR maintenance study, 45% of patients receiving guselkumab 100mg subcutaneous (SC) maintenance every eight weeks (q8w) and 50% of patients receiving guselkumab 200mg SC every four weeks (q4w) achieved clinical remission at Week 44, compared to 19% of placebo-treated patients (p<0.001). The safety profile was consistent with previously known data.
Drug Profile and Previous Approvals
Guselkumab is the first fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64. It was first approved in the European Union (EU) in November 2017 for the first-line treatment of moderate-to-severe plaque psoriasis. Subsequently, it secured approval to treat active psoriatic arthritis (PsA) in adult patients who had an inadequate response or were intolerant to prior disease-modifying anti-rheumatic drug therapy.-Fineline Info & Tech