Johnson & Johnson Seeks FDA Approval For Tremfya For Moderate To Severe Crohn's Disease

(RTTNews) - Johnson & Johnson (JNJ) announced the submission of a supplemental Biologics License Application or sBLA to the U.S. Food and Drug Administration seeking approval of Tremfya or guselkumab for the treatment of adults with moderately to severely active Crohn's disease. This marks the second submission to the FDA for Tremfya in inflammatory bowel disease this year following an application in March for moderately to severely active ulcerative colitis.

The latest submission is supported by 48-week results from the Phase 3 GALAXI and GRAVITI programs.

GALAXI includes data demonstrating superior outcomes for Tremfya versus Stelara (ustekinumab) in Crohn's disease.

Tremfya is the only IL-23 inhibitor to demonstrate strong endoscopic outcomes with subcutaneous (SC) induction, consistent with intravenous (IV) induction, and has the potential to be the first in its class to offer the option of both SC and IV induction therapy in Crohn's disease.

Janssen-Cilag International NV, a Johnson & Johnson company, previously announced the submission of applications to the European Medicines Agency (EMA) seeking to expand the Marketing Authorization Application for Tremfya to include the treatment of adult patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease.

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