Eli Lilly Nabs Breakthrough Therapy Designation for Baricitinib

The FDA granted breakthrough therapy designation to Eli Lilly’s baricitinib for treatment of alopecia areata, an autoimmune disorder that can cause hair loss on the scalp, face and other areas of the body.

The designation was granted based on the results of a phase 2 trial, in which no serious adverse events were reported. The mild or moderate adverse events included upper respiratory tract infections, nasopharyngitis and acne.

Currently marketed as Olumiant, baricitinib is currently approved in more than 65 countries including the U.S., the EU and Japan for treatment of moderate to severe active rheumatoid arthritis.