A Biologics License Application (BLA) for sirukumab, a human monoclonal IgG1 kappa antibody targeting IL-6, was submitted by Janssen Biotech to the US Food and Drug Administration (FDA) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).
The BLA submission was based on data from the phase 3 SIRROUND clinical development program, which included 5 studies: SIRROUND-D (ClinicalTrials.gov Identifier: NCT01604343), SIRROUND-T (ClinicalTrials.gov Identifier: NCT01606761), SIRROUND-H (ClinicalTrials.gov Identifier: NCT02019472), SIRROUND-M, and SIRROUND-LTE (ClinicalTrials.gov Identifier: NCT01856309).
The program enrolled over 3000 patients with active RA to investigate treatment with subcutaneous sirukumab 50mg every 4 weeks and sirukumab 100mg every 2 weeks in combination with conventional disease-modifying antirheumatic drugs (DMARDs) or as monotherapy.
SIRROUND-3 included patients who had an inadequate response to DMARDs and is expected to reach completion in 2017. SIRROUND-T included patients who had an inadequate response or were intolerant to anti-TNFα agents. SIRROUND-H included patients with an inadequate response or who were intolerant to methotrexate (MTX) or for whom MTX was inappropriate.
SIRROUND-M included Japanese patients who had an inadequate response to MTX or sulfasalazine. SIRROUND-LTE was a long-term extension study for patients completing SIRROUND-D and SIRROUND-T; this study is anticipated to reach completion in 2020.
Janssen Submits Application Seeking Approval of Sirukumab in United States for Rheumatoid Arthritis. Business Wire. Published online September 23, 2016. Accessed September 24, 2016.
This article originally appeared on MPR