Eli Lilly and Company today announced updates on the Phase 3 development program for OLUMIANT® (baricitinib) in adults with active systemic lupus erythematosus (also referred to as SLE and lupus) and the status of the U.S. atopic dermatitis supplemental new drug application (sNDA).
Based on top-line efficacy results from two pivotal Phase 3 trials (SLE-BRAVE-I and II), Lilly has decided to discontinue the Phase 3 development program for OLUMIANT in lupus.
Based on top-line efficacy results from two pivotal Phase 3 trials (SLE-BRAVE-I and II), Lilly has decided to discontinue the Phase 3 development program for OLUMIANT in lupus.
In SLE-BRAVE-I, the baricitinib 4-mg oral dose met the primary endpoint, demonstrating a statistically significant reduction in disease activity as measured by the proportion of adults with active lupus who achieved an SRI-4 response (a composite measurement of overall disease activity) at Week 52 compared to placebo. The SLE-BRAVE-II study, which also studied adults with active lupus, did not meet the primary endpoint of SRI-4 response. Key secondary endpoints were not met in either study. Safety findings from both lupus studies were consistent with previously published OLUMIANT data and did not impact our decision to discontinue the program. Lilly intends to analyze the totality of our lupus data to help inform our understanding of the disease and advance the science and intends to publish findings at a later date.
Lilly is working with investigators to appropriately conclude the Phase 3 SLE long-term extension trial, SLE-BRAVE-X, which was designed to evaluate the long-term safety and efficacy of OLUMIANT over three years in adults who completed SLE-BRAVE-I or II.