The FDA has approved the first treatment for alopecia areata, a sometimes disfiguring condition that can cause hair loss over the entire body, most noticeably patchy baldness on the head, sometimes including the loss of eyelashes and eyebrows.

The oral drug, called Olumiant (baricitinib), blocks one or more more enzymes that can lead to inflammation causing the the body to attack its own hair follicles which then makes hair fall out. The autoimmune disorder ffects more than 300,000 people in the US each year.

Olumiant, known as a JAK inhibitor, has a list price of nearly $2,500 a month, according to The New York Times, but FDA approval qualifies the treatment for insurance coverage.

Success in Two Studies

Monday's decision is based on the results of two trials which compared different doses of Olumiant with a placebo among people who had at least 50% scalp hair loss for more than 6 months.

An average of a third of the patients achieved at least 80% recovery of hair on their head after 36 weeks.

The results were reported at the annual meeting of the American Academy of Dermatology meeting in March.

The drug – sold by Eli Lilly -- was originally approved in 2018 as a treatment for adults with moderately to severely active rheumatoid arthritis, another autoimmune disorder. It is also approved for treating COVID-19 in certain hospitalized adults.

While it comes with a laundry list of potential side effects according to the FDA, including upper respiratory tract infections, headache, acne, high cholesterol, shingles, and weight gain – and there is a so-called black box warning for serious infections, cancer, blood clot and heart risks, even death – the New York Times reports that most side effects in Lilly's drug trial were relatively mild, including acne, urinary tract infections, and other infections that were easily treatable or resolved without treatment.

Two other companies, Pfizer and Concert Pharmaceuticals, also have similar drugs in late-stage development for alopecia.

Until now, the only treatments for moderate to severe alopecia areata approved by the FDA have been steroid injections, contact sensitization, and immunosuppressants, but they aren't very effective, are inconvenient to take, and have been unsuitable for use long term.

“Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata,” Kendall Marcus, MD, director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research said in an FDA press release.

Alopecia received widespread international attention earlier this year at the annual Academy Awards ceremony, when actor Will Smith walked from the audience up to the stage and struck comedian Chris Rock in the face after he directed a joke at Smith's wife, Jada Pinkett Smith, for her shaved head. Pinkett Smith has alopecia and has been public about her struggles with the disease.