Posted by Michael Wonder on 06 Apr 2021
Lilly and Incyte communicate review extension of supplemental new drug application for baricitinib for the treatment of moderate to severe atopic dermatitis
6 April 2021 - Eli Lilly and Incyte announced today that the U.S. FDA has extended the review period for the supplemental new drug application for baricitinib for the treatment of adults with moderate to severe atopic dermatitis.
The FDA extended the action date to allow time to review additional data analyses submitted by Lilly in response to recent information requests from the FDA.
The Prescription Drug User Fee Act action date has been extended three months to early Q3 2021.
