Olumiant gains marketing approval in Japan for RA

Marking its second major regulatory approval, Eli Lilly (NYSE: LLY) and Incyte Corp (Nasdaq: INCY) today revealed that Japan's Ministry of Health, Labor and Welfare (MHLW) has granted marketing approval for Olumiant (baricitinib) 2mg and 4mg tablets for the treatment of rheumatoid arthritis (RA) (including the prevention of structural injury of joints) in patients with inadequate response to standard-of-care therapies.

The Olumiant approval is based on the results of the baricitinib development program, which includes four Phase III clinical trials enrolling various populations of more than 3,000 moderate-to-severe RA patients worldwide, including more than 500 Japanese patients. In clinical studies, baricitinib has demonstrated significant improvement in the signs and symptoms of RA compared to standard-of-care therapies.

"Today is an important milestone for the RA community in Japan. 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," said Christi Shaw, president of Lilly Bio-Medicines.