FDA committee split on Olumiant dosing

FDA's Arthritis Advisory Committee voted on April 23 in favor of approving a once-daily 2 mg dose of rheumatoid arthritis candidate Olumiant baricitinib from Eli Lilly and Co. (NYSE:LLY) and partner Incyte Corp. (NASDAQ:INCY) but against a 4 mg dose.

The panel voted 10-5 that the benefit-risk profile of 2 mg once-daily Olumiant was adequate to support approval. It voted 14-1 that efficacy data support approval and 9-6 that the dose had adequate safety data...