Update on Olumiant phase III lupus program and status of atopic dermatitis sNDA.- Eli Lilly + Incyte
Lupus program update ; Based on top-line efficacy results from two pivotal Phase III trials (SLE-BRAVE-I and II), Lilly has decided to discontinue the Phase III 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 the decision to discontinue the program. Lilly intends to analyze the totality of its 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 III 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.
Atopic dermatitis regulatory update: Lilly is in ongoing discussion with the FDA regarding the status of the sNDA for Olumiant for the treatment of adults with moderate-to-severe atopic dermatitis. At this point, the company does not have alignment with the FDA on the indicated population. Given the Agency's position, there is a possibility that this could lead to a Complete Response Letter (CRL). The efficacy and safety profile of Olumiant was evaluated in eight atopic dermatitis clinical trials (six double-blind, randomized, placebo-controlled studies and two long-term extension studies) inclusive of patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The safety profile in these trials was consistent with previously published Olumiant data.
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