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FDA advisory committee rejects approval for sirukumab, voices safety concerns

17:32 EDT 2 Aug 2017 | Healio

The FDA Arthritis Advisory Committee voted 1-12 today against recommending approval of the biologics license application for sirukumab injection for the treatment of moderately to severely active rheumatoid arthritis among patients who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs.The meeting focused on one phase 2 dose ranging study and three phase 3 studies which assessed the efficacy and safety of sirukumab, an interleukin-6 (IL-6) inhibitor with the proposed trade name Plivensia (Janssen Biotech Inc.). The results showed sirukumab at doses of 50 mg every 4 weeks and 100 mg every 2 weeks effectively reduced the symptoms, delayed the progression of structural damage and improved patient reported outcomes of rheumatoid arthritis (RA), and had a similar safety profile to other biologics used in the management of RA. Janssen Biotech proposed sirukumab 50 mg every 4 weeks as the only dose for the treatment of patients with RA based on the efficacy and safety data.

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