FDA Committee Votes in Favor of Arthritis Drug’s Efficacy, Splits on Safety and Risk-Benefit Profile

An FDA advisory committee was split on Monday over several questions on Eli Lilly’s rheumatoid arthritis dosage, voting in favor of efficacy for both a 2 mg and 4 mg dosage but voting against the safety and risk-benefit profile of the larger dosage.

The recommended dosage of baricitinib, indicated for patients intolerant or unresponsive to methotrexate, is 2 mg daily, but FDA representatives asked the committee to consider a dose of 4 mg in case of an inadequate response or intolerance to more than one disease modifying anti-rheumatic drug.

The committee voted 14 to 1 in favor of the efficacy of the drug at 2 mg and 15 to 0 in favor of its efficacy at 4 mg. It voted 9 to 6, however, that there were adequate safety data to support the approval of the 2 mg dosage and voted 10 to 5 that there were insufficient data to support the 4 mg dosage.