Japan Ministry of Health, Labor and Welfare Grants Marketing Approval or Olumiant

Eli Lilly and Company and Incyte announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted marketing approval for Olumiant (baricitinib) 2-mg and 4-mg 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 3 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.

The Japan marketing authorization of Olumiant triggers a $15 million milestone payment from Lilly to Incyte, which Incyte expects to recognize, in full, in the third quarter of 2017.

Olumiant is a once-daily oral JAK inhibitor currently in clinical studies for inflammatory and autoimmune diseases. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions, including rheumatoid arthritis.

In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases. Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., European Union and Japan in 2016. Olumiant was approved in the EU in February 2017. In April 2017, the U.S. Food and Drug Administration issued a Complete Response Letter on the New Drug Application for Olumiant. Olumiant was also approved in Kuwait and Switzerland in June 2017 and approved in Japan in July 2017 for the treatment of RA.

Rheumatoid arthritis is an autoimmune disease characterized by inflammation and progressive destruction of joints. More than 23 million people worldwide suffer from RA. Approximately three times as many women as men have the disease. Current treatment of RA includes the use of non-steroidal anti-inflammatory drugs (NSAIDs), oral conventional disease-modifying antirheumatic drugs (cDMARDs) – such as methotrexate, the current standard of care, and injectable and intravenous biological disease-modifying antirheumatic drugs (bDMARDs) that target selected mediators implicated in the pathogenesis of RA.