Lilly Receives FDA Breakthrough Therapy Designation for Baricitinib for Alopecia Areata

Indianapolis: Eli Lilly and Company and Incyte Corporation has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to baricitinib for the treatment of alopecia areata (AA), an autoimmune disorder that can cause unpredictable hair loss on the scalp, face and other areas of the body. The Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over already available therapies on a clinically significant endpoint(s).

"Patients with AA currently do not have any FDA-approved treatment options available to them," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "AA not only causes hair loss but also may be a psychosocial burden for people living with this disease. At Lilly, we aspire to create new medicines that can give hope to patients. We look forward to working with the FDA to further explore baricitinib's potential to become the first approved treatment option for these individuals."

The FDA Breakthrough Therapy designation is based on the positive Phase 2 results of Lilly's adaptive Phase 2/3 study BRAVE-AA1, which evaluated treatment with baricitinib versus placebo in adult patients with AA. In the Phase 2 portion of the BRAVE-AA1 study up to Week 36, there were no new safety signals with no serious adverse events reported. The reported treatment-emergent adverse events (TEAEs) were mild or moderate and the most common included upper respiratory tract infections, nasopharyngitis and acne.

Based on the interim results of the Phase 2 part of the study, the Phase 3 portion of BRAVE-AA1 and an additional Phase 3 double-blind study (BRAVE-AA2), are currently assessing the efficacy and safety of the 2-mg and 4-mg doses of baricitinib relative to placebo.

"There are millions of people around the world affected by and living with AA," said Dory Kranz, president and CEO of the National Alopecia Areata Foundation. "We're encouraged by baricitinib's potential to be one of the first FDA-approved medicines to treat AA."

Baricitinib is currently approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). More than 100,000 patients have experience using baricitinib, which is approved in over 65 countries including the U.S., member states of the EU and Japan. It is marketed as OLUMIANT®.

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