Eli Lilly and Company and Incyte announced that the U.S. Food and Drug Administration (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 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 (PDUFA) action date has been extended three months to early Q3 2021.
“We look forward to continuing to work closely with the FDA to bring baricitinib to patients living with moderate to severe atopic dermatitis,” said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. “We remain confident in baricitinib and believe it has the potential to be an effective new treatment option for these patients.”
This extension does not affect Lilly’s previously-issued financial guidance for 2021. Ongoing research for baricitinib, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, in adult and pediatric AD, alopecia areata (AA), systemic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA), COVID-19 and for its approved indication for rheumatoid arthritis (RA) continues.