FDA committee split on Olumiant dosing

FDA's Arthritis Advisory Committee voted Monday 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.

In briefing documents released ahead of the meeting, FDA reviewers expressed concerns over a possible increased risk of thrombosis with Olumiant (see BioCentury Extra, April 19)...