FDA Grants Fast Track Designation to the Baricitinib Development Program

Eli Lilly and Company and Incyte announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to baricitinib, which is being studied for the treatment of systemic lupus erythematosus (SLE). The Fast Track designation process aims to facilitate the development and expedite the review of new medicines that treat serious conditions and fill unmet medical needs, with the goal of delivering potentially important therapies to patients sooner.

Earlier this year, positive results of a Phase 2 study of baricitinib for the treatment of SLE, which informed the FDA's Fast Track designation, were published by The Lancet and presented at the European Congress of Rheumatology.

"There has been only one new treatment for SLE approved in the U.S. in the past 50 years, and Lilly is excited to be at the forefront of potentially bringing a new treatment option to patients with this chronic, multi-organ autoimmune disease that can cause widespread tissue damage," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "As part of the Fast Track designation, we will work closely with the FDA to further explore baricitinib's potential as a treatment that can provide meaningful improvements for people with SLE."

Lilly is currently studying two doses of baricitinib in Phase 3 SLE trials. Additionally, Lilly is investigating baricitinib as a potential treatment for moderate to severe atopic dermatitis, a serious form of eczema, with Phase 3 results projected to be shared during the first half of 2019. Baricitinib is approved in over 50 countries globally as OLUMIANT® for the treatment of adults with rheumatoid arthritis.

OLUMIANT (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: Use of OLUMIANT in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

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