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FDA says Olumiant's thrombosis signal not a JAK class effect

April 19, 2018 11:46 PM UTC

FDA reviewers raised concerns over a possible increased risk of thrombosis with rheumatoid arthritis candidate Olumiant baricitinib from Eli Lilly and Co. (NYSE:LLY) and partner Incyte Corp. (NASDAQ:INCY).

In briefing documents released Thursday ahead of an April 23 meeting of FDA's Arthritis Advisory Committee, reviewers noted that clinical study reports of thrombosis is "unique risk" for Olumiant not seen with biologic disease-modifying anti-rheumatic drugs (DMARDs) or other Janus kinase (JAK) inhibitors, such as Xeljanz tofacitinib from Pfizer Inc. (NYSE:PFE). Olumiant, a JAK-1 and JAK-2 inhibitor, is approved in the EU and Japan to treat RA...