LLY - FDA extends review period for Eli Lilly Incyte's baricitinib atopic dermatitis sNDA

Eli Lilly (LLY) and Incyte (INCY) announce that the U.S. FDA has extended the review period for the supplemental New Drug Application ((sNDA)) for baricitinib for the treatment of adults with moderate to severe atopic dermatitis ((AD)).The Prescription Drug User Fee Act ((PDUFA)) action date has been extended three months to early Q3 2021.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 health regulator.This extension does not affect Lilly's previously-issued financial guidance for 2021, the companies said."We remain confident in baricitinib and believe it has the potential to be an effective new treatment option for these patients," Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines said.

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FDA extends review period for Eli Lilly, Incyte's baricitinib atopic dermatitis sNDA