Eli Lilly announced today that it has ended one of its phase 3 studies of the rheumatoid arthritis drug tabalumab. The decision to end the FLEX-M research, one of three tabalumab drug studies Eli Lilly is conducting, came after a scheduled, interim analysis. The results of the internal analysis demonstrated insufficient efficacy, according to the company.
Additional studies involving tabalumab to determine its effectiveness in treating lupus will continue. Lilly also continues to evaluate tabalumab in two other phase 3 rheumatoid arthritis registration studies in different patient populations, but is suspending enrollment of new patients in the RA program until additional analysis from ongoing studies is completed in early 2013.
According to Lilly, the decision to end the research was not safety-related, therefore patients currently enrolled in other phase 3 studies involving tabalumab will continue to receive treatment.
Dr. Eiry Roberts, vice president of autoimmune product development at Lilly, said in the company's press release: "The results of this study were unexpected given the data generated in earlier Phase II clinical studies of tabalumab. ... We remain committed to patients with rheumatoid arthritis and lupus and will move rapidly to evaluate the impact of these data on the overall tabalumab clinical development program."
The decision to stop the FLEX-M study is expected to result in a fourth-quarter pre-tax charge of $20 million to $35 million, about $0.02 per share after-tax.
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