FDA Approves Baricitinib Oral Tablets as First Systemic Alopecia Areata Treatment

The FDA has announced the approval of baricitinib (Olumiant) oral tablets for adults with severe alopecia areata, a condition affecting more than 300,000 US adults each year. The approval marks the first agency approval of a systemic treatment for the condition.

Safety and efficacy for baricitinib in alopecia areata were studied in 2 randomized, double-blind, placebo-controlled trials—BRAVE-AA1 and BRAVE-AA2 (NCT03570749 and NCT03899259)—which included patients who had at least 50% scalp hair loss for more than 6 months. Participants received either baricitinib 2 mg, baricitinib 4 mg, or placebo. Primary efficacy measurement in both trials was the proportion of patients achieving at least 80% scalp hair coverage at 26 weeks.

“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, MD, director of the Division of Dermatology and Dentistry at the FDA’s Center for Drug Evaluation and Research. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”

Common side effects included upper respiratory tract infections, headache, acne, hyperlipidemia, urinary tract infections, and elevated levels of creatinine phosphokinase, among others. Baricitinib is not recommended for use in combination with other Janus kinase inhibitors, biologic immunomodulators, cyclosporine, or other potent immune suppressors. It also includes a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.

Baricitinib was originally approved in 2018 as a treatment for moderately to severely active rheumatoid arthritis and has been approved for COVID-19 treatment in certain hospitalized adults. The drug received priority review and breakthrough therapy designations for the current indication.

Reference

FDA approves first systemic treatment for alopecia areata. News release. FDA. June 13, 2022. Accessed June 13, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-first-systemic-treatment-alopecia-areata