Two applications have been sent to the US Food and Drug Administration (FDA) for the approval of golimumab (Simponi Aria®, Jannsen Biotech) to treat adult patients with psoriatic arthritis (PsA) and active ankylosing spondylitis (AS). The company announced this week its submission of two Supplemental Biologics License Applications (sBLAs) for the anti-tumor necrosis factor (TNF)-alpha therapy, which is already FDA-approved as a combination therapy for the treatment of adults with rheumatoid arthritis (RA).
Janssen, based in Horsham, Pennsylvania, is owned by consumer healthcare giant Johnson & Johnson.
The company noted that results from 2 separate phase 3 studies resulted in submission of the sBLAs. As previously reported by Rheumatology Advisor, treatment with golimumab resulted in improving long-term function and radiographic assessments among patients with PsA in the GO-REVEAL study (A Study of the Safety and Efficacy of Golimumab in Patients With Active Psoriatic Arthritis, ClinicalTrials.gov Identifier: NCT00265096).
The FDA published an advisory for golimumab earlier this year, warning that patients receiving the drug during clinical trials were experiencing an increased incidence lymphoma. The advisory noted a 3.8-fold higher rate of lymphoma compared with the general population among 2347 patients treated with golimumab over a mean 1.4-year follow-up.
The regulator did acknowledge, however, that patients with RA and other inflammatory diseases likely have a higher baseline risk for lymphoma, even in the absence of TNF inhibitor therapy.
Janssen Submits Two Applications To FDA Seeking Approval Of SIMPONI ARIA® (golimumab) For The Treatment Of Active Psoriatic Arthritis And Active Ankylosing Spondylitis. [news release] Janssen Biotech, Inc. http://www.prnewswire.com/news-releases/janssen-submits-two-applications-to-fda-seeking-approval-of-simponi-aria-golimumab-for-the-treatment-of-active-psoriatic-arthritis-and-active-ankylosing-spondylitis-300381957.html Accessed December 22, 2016.