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ARTICLE | Clinical News

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

April 20, 2018 4:33 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 on April 19 ahead of an April 23 meeting of FDA's Arthritis Advisory Committee, reviewers noted that clinical study reports of thrombosis is a "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...