The U.S. Food and Drug Administration (FDA) has granted a Fast Track designation to Eli Lilly and Co.’s (NYSE: LLY) baricitinib, which is being studied for the treatment of systemic lupus erythematosus (SLE).
This update is based on positive results from a Phase 2 study of baricitinib for the treatment of SLE that were published by The Lancet and presented at the European Congress of Rheumatology.
Overall, 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.
Currently, Eli Lilly is currently studying two doses of baricitinib in Phase 3 SLE trials.
Lotus Mallbris, M.D., Ph.D., and vice president of immunology development at Eli Lilly, commented:
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. 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.
Shares of Eli Lilly were last seen up fractionally at $114.89, in a 52-week range of $73.69 to $119.84. The consensus analyst price target is $115.00.