Eli Lilly (LLY) to Cease Tabalumab Phase 3 RA Program
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EPS Growth %: +23.9%
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Eli Lilly and Company (NYSE: LLY) 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, ILLUMINATE, is ongoing and will continue as planned.
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 one or more tumor necrosis factor (TNF) inhibitors.
Based on the outcomes of these two separate interim futility analyses, Lilly has decided to discontinue development of tabalumab in the current RA program. All ongoing Phase 2 and Phase 3 RA studies will be stopped.
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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 one or more tumor necrosis factor (TNF) inhibitors.
Based on the outcomes of these two separate interim futility analyses, Lilly has decided to discontinue development of tabalumab in the current RA program. All ongoing Phase 2 and Phase 3 RA studies will be stopped.
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