FDA Committee Votes Against RA Drug Candidate Approval
Janssen Biotech announced that the Food and Drug Administration (FDA)'s Arthritis Advisory Committee has not recommended the approval of sirukumab (Plivensia) subcutaneous injection for the treatment of moderately to severely active rheumatoid arthritis (RA) in adults with inadequate response or who are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).
Sirukumab, a human monoclonal IgG1 kappa antibody, works differently than current IL-6 inhibitors approved to treat RA by targeting the IL-6 cytokine vs. the IL-6 receptor. The Biologics License Application (BLA) was submitted to the FDA in September 2016.
Efficacy and safety data from a Phase 3 clinical development program (five studies of >3,000 patients) were reviewed by the the Arthritis Advisory Committee. Sirukumab 50mg every 4 weeks and sirukumab 100mg every 2 weeks showed significant efficacy in treating RA, improving signs/symptoms, inhibiting the progression of structural damage, and improving patient-reported outcome measures (eg, fatigue, pain, quality of life, physical function).
Lab abnormalities, colds, upper respiratory tract infections, redness, pain, and swelling at the injection site were reported as the most common adverse events in the clinical program. Serious adverse events included pneumonia, cellulitis, abscess, sepsis, osteomyelitis, hypersensitivity reactions, low platelets, lipid elevations, gastrointestinal perforations. In addition, cardiovascular effects, malignancies, and death were seen in clinical studies.
The Committee voted unanimously to support the efficacy data of sirukumab but did not fully support its benefit-to-risk profile. The FDA is not tied to the Committee's recommendation but it takes its advice into consideration.
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