NEW BRUNSWICK (dpa-AFX) - 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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