The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Eli Lilly and Company and Incyte Corporation’s baricitinib for the treatment of alopecia areata (AA).

Baricitinib is currently approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).

"Patients with AA currently do not have any FDA-approved treatment options available to them," says Lotus Mallbris, MD, PhD, 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," says 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."