RA Drug Not Recommended for Approval by FDA Panel
The Arthritis Advisory Committee of the US Food and Drug Administration has not recommended approval of sirukumab for the treatment of moderately to severely active rheumatoid arthritis (RA) in adults with inadequate response or intolerance to one or more disease modifying anti-rheumatic drugs.
The benefits of the anti-interleukin (IL)-6 monoclonal antibody did not outweigh its risks, according to the panel, which voted 12-1 against the approval. Chief among their concerns was an unbalanced number of deaths in patients taking sirukumab compared with those taking placebo. The most common causes of death included adverse cardiac events, infections, and malignancies.
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Study: Obesity Skews Rheumatoid Arthritis Biomarker
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Further, the panel cited the availability of 2 other drugs that are in the same class as sirukumab as a cause for reluctance to approve.
Although the FDA is not obligated to follow the panel’s recommendation, it often does.
—Michael Potts
Reference:
FDA advisory committee does not recommend approval of sirukumab for the treatment of moderately to severely active rheumatoid arthritis [press release]. August 2, 2017. Horsham, Pennsylvania. https://www.janssen.com/fda-advisory-committee-does-not-recommend-approval-sirukumab-treatment-moderately-severely-active.
