(CercleFinance.com) – Eli Lilly announces that it has decided to discontinue its phase 3 program of Olumiant (baricitinib) in adults with systemic lupus erythematosus, based on initial efficacy results from two pivotal phase 3 trials (SLE-BRAVE-I and II)
While Study I met the primary endpoint, demonstrating a statistically significant reduction in disease activity at week 52 compared to placebo, Study II did not meet the primary endpoint. In addition, key secondary endpoints were not met in either study.
Eli Lilly intends to analyze all the data on lupus to inform his understanding of the disease.
In addition, the laboratory indicates that it is in discussion with the Food and Drug Administration (FDA) of the United States within the framework of an application for additional indication of Olumiant as a treatment for adults suffering from moderate to severe atopic dermatitis.
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