FDA panel to review Lilly's Olumiant

FDA's Arthritis Advisory Committee will meet on April 23 to discuss an NDA for Olumiant baricitinib from Eli Lilly and Co. (NYSE:LLY) to treat moderately to severely active rheumatoid arthritis. Lilly resubmitted the NDA after receiving a complete response letter in April 2017 (see BioCentury Extra, April 14, 2017).

Olumiant is approved in the EU and Japan to treat RA. The drug is a Janus kinase-1 (JAK-1) and JAK-2 inhibitor.

Lilly has rights to Olumiant under a deal with Incyte Corp. (NASDAQ:INCY). Incyte was off $3.57 to $88.69 on Thursday.

Lilly is relying on key launches, including Olumiant's, to offset the loss of patent coverage for several top-selling drugs (see BioCentury, Oct. 24, 2016).