Review period for Olumiant (baricitinib) NDA in rheumatoid arthritis extended by US FDA - Eli Lilly

The FDA has extended the review period for the new drug application (NDA) for investigational Olumiant (baricitinib), from Eli Lilly, a once-daily oral medication for the treatment of moderate to severe rheumatoid arthritis. The NDA for baricitinib was submitted to the FDA in January 2016.

The FDA extended the action date to allow time to review additional data analyses recently submitted by Lilly in response to the FDA's Information Requests. The submission of the additional information has been determined by the FDA to constitute a Major Amendment to the NDA, resulting in an extension of the Prescription Drug User Fee Act goal date by three months.

Comment: Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., European Union and Japan in Q1 2016. The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion in December 2016, recommending the approval of baricitinib.