The FDA has announced that it has approved Lilly’s Olumiant (baricitinib) oral tablets to treat adults with severe alopecia areata, a form of baldness resulting from the body attacking its hair follicles.
Manifesting as patchy baldness, alopecia areata affects more than 300,000 people in the U.S.
The incidence of alopecia areata is growing.
“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Dr. Kendall Marcus, director of the division of dermatology and dentistry in the FDA’s Center for Drug Evaluation and Research, in a news release. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”
FDA first approved Olumiant in 2018 for rheumatoid arthritis. In 2022, the drug won an indication for COVID-19 in some hospitalized COVID-19 patients.
Image courtesy of Lilly
Baricitinib is an oral JAK inhibitor.
Researchers have also successfully used another JAK inhibitor, Xeljanz (tofacitinib) from Pfizer (NYSE:PFE), to treat severe alopecia areata. In May, NEJM published a summary of Phase 3 studies of baricitinib for alopecia areata.
In 2021, Olumiant sales were $1.115 billion, marking a 59% increase over the prior year.
To win approval for alopecia areata, Lilly included Olumiant in two randomized, double-blind, placebo-controlled studies known as Trial AA-1 and Trial AA-2.
Volunteers in the study had at least 50% scalp hair loss and received either a daily placebo or 2- or 4-mg of Olumiant.
The study’s primary endpoint was at least 80% scalp hair coverage at week 36.
Approximately one-third of recipients of 4 mg of Olumiant achieved adequate scalp hair coverage in the studies.
After one year, approximately half of the patients had substantial hair regrowth.
In addition to Pfizer, Concert Pharmaceuticals is also developing a JAK inhibitor for alopecia areata.