BLA Submitted for Investigational RA Drug
Janssen Biotech announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for the approval of sirukumab 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 a total of 5 studies: SIRROUND-D, SIRROUND-T, SIRROUND-H, SIRROUND-M, and SIRROUND-LTE. The program enrolled over 3,000 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.
Sirukumab, a human monoclonal IgG1 kappa antibody, targets the cytokine IL-6 protein that is presumed to play a role in autoimmune conditions.
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