Japanese regulator clears Eli Lilly, Incyte's Olumiant for treatment of rheumatoid arthritis

Eli Lilly and partner Incyte announced Monday that Japan's Ministry of Health, Labour and Welfare approved the once-daily oral JAK inhibitor Olumiant (baricitinib) for the treatment of rheumatoid arthritis (RA) in patients with inadequate response to standard therapies. The decision was based on a review of data from four late-stage trials of more than 3000 patients with moderate-to-severe RA worldwide, including over 500 Japanese patients. 

Christi Shaw, president of Lilly Bio-Medicines, said the approval marks "an important milestone for the RA community in Japan," where the companies estimate that 700 000 to 800 000 patients suffer from the disease. Meanwhile, Incyte's chief medical officer Steven Stein noted that the Phase III programme for Olumiant "consistently showed significant improvement in clinical signs and symptoms of RA in a wide range of RA patients with a diverse treatment history." 

FirstWord reports in this therapy area: KOL Insight Rheumatoid Arthritis: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more

The drug was authorised in Europe in February, but was rejected by the FDA in April, with the agency asking for more data related to dosing and safety. At the time, Eli Lilly and Incyte indicated that the timing of a resubmission would depend on discussions with the US agency. 

For related analysis, see ViewPoints: EMA's (positive) review may offer clues about FDA's (negative) decision on Olumiant. See also Physician Views Poll Results: Olumiant given positive assessment by rheumatologists ahead of potential US approval.

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