Johnson & Johnson submits regulatory applications to European Medicines Agency for TREMFYA® (guselkumab) for treatment of patients with ulcerative colitis and Crohn's disease [Yahoo! Finan...
Johnson & Johnson (JNJ)
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Source: Yahoo! Finance
For European and UK medical and trade media only For immediate release Johnson & Johnson submits regulatory applications to European Medicines Agency for TREMFYA ® (guselkumab) for treatment of patients with ulcerative colitis and Crohn's disease Submission included data from the Phase 3 QUASAR programme in ulcerative colitis and the Phase 3 GALAXI programme in Crohn's disease, which each achieved their primary endpoints Beerse, Belgium (May 01, 2024) – Janssen-Cilag International NV, a Johnson & Johnson company, today announced it has submitted applications to the European Medicines Agency (EMA) seeking to expand the Marketing Authorisation Application for TREMFYA ® (guselkumab) to include the treatment of adult patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease. The submission included data from the Phase 3 QUASAR programme in ulcerative colitis and the Phase 3 GALAXI programme in Crohn's disease. In the Phase
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