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  • 平井 将秀


Feb. 7, 2013 -- Eli Lilly and Company announced today that it will discontinue the Phase 3 rheumatoid arthritis (RA) program for tabalumab, an anti-BAFF (B cell activating factor) monoclonal antibody, due to lack of efficacy. The decision was not based on safety concerns. The tabalumab Phase 3 program for systemic lupus erythematosus is ongoing and will continue as planned.

イーライリリー・アンド・カンパニーは7日、関節リウマチに対する抗BAFF(B細胞活性化因子)モノクローナル抗体「tabalumab」の効果が不十分であることから、その第三相試験計画を中止することを発表しました。 この決定は安全性の懸念に基づくものではありません。全身性エリテマーデスを適応症としたtabalumabの第三相試験は継続中であり、今後も予定通り進行します。

In December 2012, Lilly discontinued the Phase 3 RA registration study FLEX-M for lack of treatment effect. FLEX-M was investigating tabalumab in patients with moderate-to-severe RA who had an inadequate response to methotrexate therapy.


Based on FLEX-M findings, an interim futility analysis was conducted of the FLEX-V study, which was investigating tabalumab for the treatment of patients with moderate-to-severe RA who had an inadequate response to tumor necrosis factor (TNF) inhibitors.


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