Earlier this week, the Food and Drug Administration (FDA) approved a new drug, Olumiant (baricitinib), which was originally approved in 2018 for the treatment of rheumatoid arthritis. Olumiant is now FDA-approved for “systemic treatment” of alopecia and can be taken in tablet form.
Alopecia areata is a type of autoimmune disease that affects the skin, creating bald patches. It is estimated that nearly 2.5 million Americans suffer from alopecia today.
This disease develops when the immune system mistakenly attacks hair follicles, leading to hair loss, according to the American Academy of Dermatology Association (AAD). Alopecia does not only create bald patches on the scalp. It can affect any area of the body that grows hair.
The approval of Olumiant for systemic treatment allows alopecia to be managed anywhere it affects the body. This is the first systemic treatment for alopecia available on the market.
Kendall Marcus, M.D., the director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research, said, “Safe and effective treatment options [are] crucial for [a] significant number of Americans affected by severe alopecia. Olumiant will help fulfill a significant unmet need for patients with severe alopecia areata.”
Olumiant was studied in two randomized, double-blind, placebo-controlled trials with patients who had at least 50% hair loss. Both randomized studies showed 80% scalp hair regrowth around the 36-week mark for those given Olumiant in the trials.
Side effects may be present when taking Olumiant. According to the FDA site on the drug, the list includes the following: upper respiratory tract infections, headaches, acne, high cholesterol (hyperlipidemia), increase of an enzyme called creatinine phosphokinase, urinary tract infections, liver enzyme elevations, inflammation of hair follicles (folliculitis), fatigue, lower respiratory tract infections, nausea, genital yeast infections (Candida infections), anemia, lower counts of certain white blood cells (neutropenia), abdominal pain, shingles (herpes zoster), and weight increase.
Olumiant got a priority review and has been shown to drastically improve hair loss in those suffering from alopecia when prescribed by their doctor.
