Eli Lilly, INCY Say Japan Grants Marketing Approval for Olumiant Tablets

Eli Lilly and Incyte said premarket Monday that Japan’s Ministry of Health, Labor and Welfare (MHLW) granted marketing approval for Olumiant 2-mg and 4-mg tablets for the treatment of rheumatoid arthritis (RA) in patients with inadequate response to standard-of-care therapies.

In Japan, an estimated 700,000-800,000 people suffer from RA, and women are three times more likely to be affected than men. “Today is an important milestone for the RA community in Japan,” Christi Shaw, president of Lilly Bio-Medicines, said in a statement. “Olumiant has been shown to provide effective relief of RA symptoms in people who do not respond to standard treatments, as well as prevent the structural damage to joints that makes RA a progressive, debilitating disease.” The Japan marketing authorization of Olumiant triggers a $15 million milestone payment to Incyte from Lilly. Incyte expects to recognize the payment, in full, in Q3.

By Jon Flanagan