FDA Approves Baricitinib for Alopecia Areata in Adults

The US Food and Drug Administration (FDA) approved oral baricitinib (Olumiant) tablets for the treatment of severe alopecia areata in adult patients.

This is the first FDA approval of a systemic treatment for the disorder, which is estimated to affect 300,000 patients in the US.

This approval was supported by data from Trial AA-1 and Trial AA-2, which were randomized, double-blind, placebo-controlled trials that featured patients with at least 50% scalp hair loss for more than 6 months as measured by the Severity of Alopecia Tool.

Regarding the first trial, 22% of the 184 patients who were treated with 2 milligrams of baricitinib and 35% of 281 patients who received 4 milligrams of baricitinib achieved adequate scalp hair coverage compared to 5% of the 189 patients on placebo.

Similarly, 7% of the 156 patients who received 2 milligrams of Olumiant and 32% of the 234 patients who received 4 milligrams of Olumiant achieved adequate scalp hair coverage in Trial AA-2 compared to 3% of the 156 patients on placebo.

“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 in the FDA’s Center for Drug Evaluation and Research in a press release by the FDA. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”

The most common side effects observed with baricitinib included upper respiratory tract infections, headache, acne, high cholesterol (hyperlipidemia), increase of an enzyme called creatinine phosphokinase, urinary tract infection, liver enzyme elevations, inflammation of hair follicles (folliculitis), fatigue, lower respiratory tract infections, nausea, genital yeast infections, anemia, low number of certain types of white blood cells, abdominal pain, shingles, and weight increase.

Previously, promising data from 2 separate phase 3 trials involving the Janus kinase (JAK) inhibitor were reported on by HCPLive at the American Academy of Dermatology (AAD) 2022 Annual Meeting in Boston.

In an interview with HCPLive, Brett King, MD, PhD, Yale School of Medicine, New Haven, spoke of the potential of baricitinib for patients with alopecia areata.

“This is this is all new territory, but JAK inhibitors are showing efficacy,” King said. “Now having 2 phase 3 clinical trials done with baricitinib, we're really advancing towards the goal of FDA approved therapies in a disease that has no FDA approved therapies, and so it's epic, it's historic, it's super exciting.”

The FDA granted the approval of Olumiant to Eli Lilly and Company.