Japan approves Olumiant for rheumatoid arthritis. | Courtesy of Pixabay.com
+ Regulatory
Carrie Bradon | Jul 9, 2017

Japanese Ministry of Health, Labor and Welfare approves Olumiant

The Japan Ministry of Health, Labor and Welfare has given marketing approval for Olumiant 2 mg and 4 mg tablets for treating rheumatoid arthritis (RA).

The treatment from Eli Lilly and Co. and Incyte Corp. has been approved for patients who are not responding to standard-of-care therapies, according to a press release. It is based on the baricitinib development program, which shows the capability of dramatically improving the symptoms of RA through baricitinib.

"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," Christi Shaw, president of Lilly Bio-Medicines, said in the release.

Between 700,000 and 800,000 people suffer from RA in Japan, and women are three times more likely to suffer from it than men.

"The phase 3 clinical trial program of Olumiant consistently showed significant improvement in clinical signs and symptoms of RA in a wide range of RA patients with a diverse treatment history," Steven Stein, chief medical officer of Incyte Corp. said in the release.

As a result of the approval in Japan Incyte will receive a $15 million payment from Lilly.

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