Subsequent Events

6 Months Ended

Jun. 30, 2017

Subsequent Events

Subsequent Events

16.    Subsequent Events

In July 2017, Japan’s Ministry of Health, Labor and Welfare granted marketing approval for baricitinib for the treatment of rheumatoid arthritis in patients with inadequate response to standard-of-care therapies and we will record a $15.0 million regulatory milestone payment in the third quarter of 2017. 

In July 2017, we and Lilly announced that a resubmission to the FDA for the NDA for baricitinib will be delayed for a period anticipated to be a minimum of 18 months. The companies will be further discussing the path forward with the agency and evaluating options for resubmission, including the potential for an additional clinical study, as requested by the FDA.  The companies continue to disagree with the FDA’s conclusions.