New EC approval for J&J’s Tremfya scores a first
US healthcare giant Johnson & Johnson (NYSE: JNJ) today announced that the European Commission (EC) has approved the expansion for the marketing authorization for Tremfya (guselkumab) to include a subcutaneous (SC) induction option for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
The new approval makes guselkumab the first interleukin (IL)-23 inhibitor to offer both SC and intravenous (IV) induction dose options for the treatment of UC and Crohn’s disease. Tremfya is already one of J&J’s best selling drugs, generating third-quarter revenues of $1.42 billion, up 41% rise year-on-year.
J&J said this accelerated regulatory milestone highlights the strength of the guselkumab data, just 32 days after the positive CHMP opinion and with approval originally expected in January 2026. This comes after J&J’s preliminary CHMP Rapporteur Assessment report concluded that the variation should be recommended without a second request for supplementary information.
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