Benzinga | Jul 16, 2021 10:04AM EDT

Eli Lilly And Co, Incyte Say FDA Will Not Meet Prescription Drug User Fee Act Action Date For Supplemental New Drug Application For Baricitinib For Treatment Of Adults With Moderate To Severe Atopic Dermatitis

Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today that the U.S. Food and Drug Administration (FDA) will not meet the Prescription Drug User Fee Act (PDUFA) action date for the supplemental new drug application (sNDA) for baricitinib for the treatment of adults with moderate to severe atopic dermatitis (AD). The delay is related to the FDA's ongoing assessment of JAK inhibitors.

"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, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, is approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in more than 75 countries. It is also approved in over 40 countries for the treatment of adults with moderate to severe AD who are candidates for systemic therapy and approved in Japan for the treatment of certain hospitalized patients with COVID-19. Baricitinib is being studied in alopecia areata (AA), systemic lupus erythematosus (SLE) and juvenile idiopathic arthritis (JIA).

This action does not affect Lilly's previously issued financial guidance for 2021.

Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patients

OLUMIANT(r) (baricitinib) 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.