Eli Lilly and Company and Incyte Corporation Announces the U.S. Food and Drug Administration Extends the Review Period for the New Drug Application

Eli Lilly and Company and Incyte Corporation announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the new drug application (NDA) for investigational baricitinib, a once-daily oral medication for the treatment of moderate to severe rheumatoid arthritis (RA). 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 (PDUFA) goal date by three months.