After FDA Rejection, Lilly's Olumiant Gets Japan Nod

Jul 04, 2017


Eli Lilly and Company and partner, Incyte Corp., announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted marketing approval for rheumatoid arthritis treatment, Olumiant.

The approval triggers a $15 million milestone payment from Eli Lilly to Incyte, which should happen in the third quarter of 2017.

The treatment, a JAK inhibitor, was approved in the EU in February 2017 and recently recommended by NICE to treat rheumatoid arthritis in adults who have not responded to conventional therapy. In April 2017, however, Incyte received a Complete Response Letter from the U.S. FDA for Olumiant. The FDA requires additional clinical data, which will delay the approval of the drug. 

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