FDA Approves Baricitinib for Advanced Alopecia Areata

June 13 2022: FDA Approves Baricitinib for Alopecia Areata

June 13, 2022 is an important day in the world of alopecia areata. Today, the FDA granted approval for the drug baricitinib (Olumiant) to be used in treating advanced alopecia areata. It marks the very first medication ever formally approved for treating alopecia areata - an autoimmune disease that affects 1-2 % of the world.

The BRAVE AA 1 and BRAVE AA 2 trials were the clinical trials that convinced the FDA to approve this drug. The trials showed that about 25-30 % of patients with advanced forms of alopecia areata achieve significant amounts of hair regrowth with baricitinib.

I reviewed these trails in Season 1, Episode 9 of the evidence based podcast.

A partial list of side effects with baricitinib include respiratory infections, urinary tract infections, shingles, increased cholesterol, increased CK muscle enzymes, acne, and changes in blood counts and gastrointestinal issues.

Olumiant comes with a boxed warning for serious infections, mortality, cancer, major adverse cardiovascular events and thrombosis (blood clots)