Resubmission of Olumiant(baricitinib )to the FDA for the treatment of rheumatoid arthritis will be delayed beyond 2017- Eli Lilly + Incyte Corporation
Eli Lilly and Company and Incyte Corporation announced that a resubmission to the FDA for the New Drug Application (NDA) for Olumiant ( baricitinib ), a once-daily oral medication for the treatment of moderate-to-severe rheumatoid arthritis (RA), will be delayed beyond 2017. 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 length of time to a resubmission for the NDA will depend on which option the companies pursue and further FDA discussions, but is anticipated to be a minimum of 18 months..
Olumiant was approved in Japan earlier this month and has approvals in the EU and UK.
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