Eli Lilly Expects FDA Rejection For Expanded Use Baricitinib For Eczema
Based on top-line efficacy results from two pivotal Phase 3 trials Eli Lilly And Co (NYSE: LLY) has decided to discontinue the Phase 3 development program for Olumiant in systemic lupus erythematosus (SLE).
In SLE-BRAVE-I, the baricitinib 4-mg oral dose met the primary endpoint, demonstrating a statistically significant reduction in disease activity compared to placebo.
The SLE-BRAVE-II study, which also studied adults with active lupus, did not meet the primary endpoint of reduction in disease activity.
Key secondary endpoints were not met in either study.
Lilly is working with investigators to appropriately conclude the Phase 3 SLE long-term extension trial, designed to evaluate the long-term safety and efficacy of Olumiant over three years in adults.
Eli Lilly also expects the FDA to decline the expanded use of baricitinib as a treatment for adults with moderate-to-severe eczema.
"At this point, the company does not have alignment with the FDA on the indicated population," the drugmaker said.
Given the Agency's position, there is a possibility that this could lead to a Complete Response Letter.
Olumiant, a once-daily, oral JAK inhibitor was discovered by Incyte Corporation (NASDAQ: INCY) and licensed to Lilly
Price Action: LLY shares are up 1.39% at $240.01 during the market session on the last check Friday.
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