> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Janssen Files Tremfya sBLA for Psoriatic Arthritis
- URL: https://www.fdaweb.com/janssen-files-tremfya-sbla-for-psoriatic-arthritis/
- Published: 2019-09-16T12:00:00.000Z
- Updated: 2026-09-15T01:50:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145012

Janssen Pharmaceutical has submitted a supplemental BLA for Tremfya (guselkumab) for treating adult patients with active psoriatic arthritis. The human monoclonal antibody was approved originally 7/2017 for treating adult patients with moderate to severe plaque psoriasis. Janssen says the sBLA is based on results from the Phase 3 DISCOVER-1 and DISCOVER-2 studies, which met their primary endpoints of patients achieving an American College of Rheumatology 20% improvement response after 24 weeks of treatment. The drug’s safety profile was generally consistent with previous studies as well as the current Tremfya prescribing information, Janssen says.