FDA Decision Delayed for Baricitinib for Atopic Dermatitis

The FDA has decided to delay the PDUFA goal date for baricitinib for treatment of adults with moderate to severe atopic dermatitis.

Joining a list of other potential new drugs, the FDA will not meet the Prescription Drug User Fee Act (PDUFA) date for the supplemental new drug application (sNDA) for baricitinib (Olumiant; Eli Lilly and Incyte) for the potential treatment of adults with moderate to severe atopic dermatitis, according to an announcement by Eli Lilly.1

The FDA cites its ongoing assessment of JAK inhibitors for the delay.

"We are confident in the efficacy and safety of baricitinib data supporting a favorable benefit-risk profile for the treatment of atopic dermatitis and look forward to continuing to work with the FDA during the remainder of the review process," said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. "We are committed to bringing baricitinib to market to help meet the needs for people living with atopic dermatitis."

Baricitinib is an an oral JAK inhibitor first discovered by Incyte and licensed to Lilly. It is currently approved for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) in over 75 countries. Also, It is approved in more than 40 countries for the treatment of adults with moderate to severe atopic dermatitis who are candidates for systemic therapy. In Japan, it is approved for the treatment of certain hospitalized patients with COVID-19.

Currently, baricitinib is being investigated as a potential treatment for alopecia areata (AA), systemic lupus erythematosus (SLE) and juvenile idiopathic arthritis (JIA).

Reference:

1. Lilly and Incyte provide update on supplemental New Drug Application for baricitinib for the treatment of moderate to severe atopic dermatitis | Eli Lilly and Company. Accessed July 22, 2021. https://investor.lilly.com/news-releases/news-release-details/lilly-and-incyte-provide-update-supplemental-new-drug