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 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 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.