The Japan Ministry of Health, Labor and Welfare has granted Indianapolis-based Eli Lilly and Co. (NYSE: LLY) and Delaware-based Incyte Corp. (Nasdaq: INCY) marketing approval for a once-daily treatment of rheumatoid arthritis. Lilly says the approval for Olumiant is based on four phase 3 clinical trials.
The approval is for 2-mg and 4-mg tablets of Olumiant, also known as baricitinib, which Lilly says will be used by patients with inadequate responses to standard-of-care therapies. The pharmaceutical company says the clinical trials included more than 3,000 moderate-to-severe RA patients throughout the world, including more than 500 from Japan.
"Today is an important milestone for the RA community in Japan," said Christi Shaw, president of Lilly Bio-Medicines. "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."
Lilly says the approval triggers a $15 million milestone payment from Lilly to Incyte, which is expected to occur in the third quarter.
Earlier this year, the U.S. Food and Drug Administration rejected a new drug application for the treatment, saying more clinical results were needed.