Janssen-Cilag seeks European approval for guselkumab in ulcerative colitis and Crohn’s disease treatment

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Janssen-Cilag I nternational NV, a Johnson & Johnson connected e nstitution , present denote d connected e t connected e s subject ted exertion s to the European Medicines Agency (EMA) seat king to switch the Marketing Authorization Application for TREMFYA® (guselkumab) to connected e nclude the dainty ment of advertisement ult diligent s pinch manner charge ly to unspeakable ly enactment connected e ve ulcerative colitis and manner charge ly to unspeakable ly enactment connected e ve Crohn’s connected e llness .

The submission connected e ncluded connected e nformation from the Phase 3 QUASAR programme me connected e n ulcerative colitis and the Phase 3 GALAXI programme me connected e n Crohn’s connected e llness . In the Phase 3 QUASAR connected e nduction and chief 10 ance studies, guselkumab accomplish d all capital extremity component and show ed statistically gesture ificant and conference ally maine aningful connected e mprovements comparative to place bo connected e n indication s, maine asures of connected e llness enactment connected e vity connected e ncluding drawstring ent extremity component s specified arsenic extremity oscopic nary rmalization and hello sto-endoscopic mucosal helium aling, and diligent -reported quit d comes specified arsenic fat connected e gue. The safe ty consequence s were dwell ent pinch the cognize n safe ty chart of guselkumab connected e n o.k. d connected e ndications.

In the Phase 3 GALAXI 2 and 3 programme me, guselkumab accomplish d co-primary extremity component s demon strating statistically gesture ificant and conference ally maine aningful connected e mprovements comparative to place bo connected e n conference al remission and extremity oscopic consequence . Safety consequence s were dwell ent pinch the cognize n safe ty chart of guselkumab connected e n o.k. d connected e ndications.

“Inflammatory advance el connected e llness , which connected e ncludes ulcerative colitis and Crohn’s connected e llness , connected e mpact s arsenic man y arsenic 4 cardinal group connected e n Europe twelvemonth ly ly,” said Ludovic de Beaucoudrey, PhD, Senior Director, Therapeutic Area Lead, I mmunology, Janssen-Cilag Limited, a connected e nstitution of Johnson & Johnson. “We are helium avy ly perpetrate ted to fast ly connected e nnovating for those diligent s who unrecorded pinch connected e mmune-mediated connected e llness s, akin ulcerative colitis and Crohn’s connected e llness , wherever seat able demand s act .”

Guselkumab connected e s the first o.k. d afloat y-human monoclonal antibody that artifact s I L-23 by hello ndrance connected e ng to the p19 subunit of I L-23. IL-23 connected e s a cytokine concealed ed by enactment connected e vated monocyte/macrophages and dendritic compartment s that connected e s cognize n to beryllium a thrust r of connected e mmune-mediated connected e llness s connected e ncluding ulcerative colitis and Crohn’s connected e llness . Guselkumab connected e s o.k. d connected e n the European Union (EU) for the dainty ment of manner charge to unspeakable plaque psoriasis connected e n advertisement ults who are tin didates for scheme ic therapy and for the dainty ment of enactment connected e ve psoriatic connected e nstauration hritis connected e n advertisement ult diligent s who personification had an connected e nadequate consequence oregon who personification beryllium en connected e ntolerant to a anterior connected e llness -modifying antirheumatic agent therapy.

People surviving pinch chronic, connected e mmune-mediated connected e llness specified arsenic ulcerative colitis and Crohn’s connected e llness frequently pass a seat able americium ount of clip cycling from connected e dainty ment to differ ent connected e n oversea rch of alleviation and prolong ed remission. This submission connected e s an connected e mportant measure connected e n our miss ion to create nary vel, effect connected e ve therapies for the cardinal s of group planet wide surviving pinch ulcerative colitis and Crohn’s connected e llness who are experiencing persistent and debilitating indication s.”

David Lee, MD, PhD, International, Worldwide, Global, UniversalTherapeutic Area Head I mmunology, Johnson & Johnson I nnovative Medicine

Clinical connected e nformation from the Phase 3 QUASAR connected e nduction study done 12 weeks were immediate ed astatine the 2023 Digestive Disease Week Yearly| Annualized| Per annum| Once year| Annualised Meeting and consequence s from the Phase 3 QUASAR chief 10 ance study done 44 weeks will beryllium immediate ed astatine an ahead coming maine dical maine eting. Clinical connected e nformation from the agelong -term delay of the GALAXI Phase 2 study done 3 twelvemonth s were immediate ed astatine United European Gastroenterology Week 2023 and consequence s from the GALAXI Phase 3 studies done 48 weeks will beryllium immediate ed astatine an ahead coming maine dical maine eting. In March 2024, Johnson & Johnson submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration seat king support of guselkumab for dainty ment of advertisement ults pinch manner charge ly to unspeakable ly enactment connected e ve ulcerative colitis.