Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee recommended approval of the 2-mg dose of baricitinib, a once-daily oral medication for the treatment of moderately-to-severely active rheumatoid arthritis (RA) for adult patients who have had an inadequate response or intolerance to methotrexate. While the Advisory Committee unanimously supported the efficacy of the 4-mg dose of baricitinib, it did not recommend approval of the 4-mg dose of baricitinib for the proposed indication based on the adequacy of the safety and benefit-risk profiles.
Eli Lilly and Incyte’s second attempt to get U.S. approval of rheumatoid arthritis drug baricitinib could be scuppered again by lingering FDA concerns about safety. A briefing document published ahead of the April 23 advisory committee meeting on baricitinib suggests that Lilly and Incyte’s lightning-fast amendment and refile of the dossier hasn’t added enough data to persuade the FDA to change its stance on the risk of blood clots with the JAK inhibitor.
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