Eli Lilly and Incyte announced Monday that an FDA advisory committee voted in favour of approval of a 2-mg dose of Olumiant (baricitinib) for the treatment of adults with moderately-to-severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Meanwhile, the panel voted by the same margin against recommending approval of the higher 4-mg dose
The drugmakers noted that while the advisory committee unanimously supported the efficacy of the higher dose of the therapy, it did not recommend its approval based on safety and benefit-risk profiles. President of Lilly Bio-Medicines Christi Shaw commented "while we are disappointed with the advisory committee's assessment of the data for the 4-mg dose, we are confident in the positive benefit-risk profile of both the 2-mg and the 4-mg doses," adding "we look forward to continuing our work with the FDA ....and are hopeful that baricitinib will receive approval in the coming months."
The panel vote comes after the FDA previously rejected the drugmakers' initial marketing application of the treatment last April. In documents released ahead of the panel vote, FDA staff expressed concerns over the risk of thrombosis linked to the higher dose of Olumiant in addition to dosing schedule issues.
The drugmakers indicated that the advisory committee's recommendation was based on a global development programme of the therapy, which included four completed Phase III trials. In study data unveiled in 2015, the JAK inhibitor has shown superiority versus placebo after 12 weeks of treatment in terms of improving signs and symptoms of moderate-to-severe rheumatoid arthritis. Similar results were also reported the prior year in a second late-stage trial.
Analysts have suggested that approval of only the lower dose of the therapy would severely limit revenue for Eli Lilly and Incyte, noting that the drugmakers viewed the once-daily oral JAK inhibitor as a potential blockbuster. Olumiant received approval in Japan last July and was also authorised in Europe in February last year.
For related analysis, see ViewPoints: FDA tentatively clears the way for JAK inhibitors- except for Eli Lilly's.
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