FDA Extends Review Period for Baricitinib

The FDA extended the review period for Eli Lilly’s NDA for baricitinib, a once-daily oral medication for the treatment of rheumatoid arthritis. The NDA was first submitted last January.

The agency extended the action date to allow time to review additional data analyses recently submitted by Lilly in response to information requests.

The submission of additional information constituted a major amendment to the NDA, the agency said, resulting in a three month extension of the required review period under the  Prescription Drug User Fee Act.