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Eli Lilly Expects FDA Rejection For Expanded Use Baricitinib For Eczema

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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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