Johnson & Johnson Submits Application To FDA Seeking Approval Of TREMFYA For Treatment Of Moderately To Severely Active Crohn's Disease
Portfolio Pulse from Benzinga Newsdesk
Johnson & Johnson has submitted an application to the FDA for the approval of TREMFYA for the treatment of moderately to severely active Crohn's disease. The submission is backed by 48-week results from the Phase 3 GALAXI and GRAVITI programs, showing strong endoscopic outcomes with both subcutaneous and intravenous induction therapies.

June 20, 2024 | 8:30 pm
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POSITIVE IMPACT
Johnson & Johnson has submitted an application to the FDA for the approval of TREMFYA for treating Crohn's disease, supported by positive Phase 3 results. This could potentially expand their product offerings and market share in the treatment of Crohn's disease.
The submission of TREMFYA for FDA approval, supported by strong Phase 3 results, indicates a potential new revenue stream for Johnson & Johnson. If approved, TREMFYA could become a significant player in the Crohn's disease treatment market, enhancing JNJ's product portfolio and market position.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100