Posted by Michael Wonder on 16 Sep 2019
Janssen submits application to U.S. FDA seeking first-in-class approval of Tremfya (guselkumab) for treatment of adults with active psoriatic arthritis
16 September 2019 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental biologics license application to the U.S. FDA seeking first-in-class approval of Temfya (guselkumab) for the treatment of adult patients with active psoriatic arthritis.
Developed by Janssen, Tremfya is a human monoclonal antibody against the p19 subunit of interleukin (IL)-23. TREMFYA is the first approved selective IL-23 inhibitor.
The Tremfya submission 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.
