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First Pill For Severe Alopecia Areata Hair Loss Given FDA Approval

Despite the vast impact of alopecia areata, this is the first systemic treatment ever approved by the FDA.


Tom Hale

Tom is a writer in London with a Master's degree in Journalism whose editorial work covers anything from health and the environment to technology and archaeology.

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Alopecia areata
It’s estimated that around 6.8 million people in the US are affected by alopecia areata. Image credit: Alex Papp/

A first-of-its-kind alopecia drug has just been approved by the US Food and Drug Administration (FDA), offering fresh hope for the millions of people in the US who experience severe hair loss as a result of the autoimmune condition. 

The once-a-day pill, known as baricitinib (sold under the brand name Olumiant), is used to treat severe alopecia areata, an autoimmune condition that attacks the body's own hair follicles, resulting in patchy hair loss. The drug works by inhibiting the action of specific enzymes that are involved in a pathway that leads to inflammation.


The FDA granted the approval of Olumiant to pharmaceutical giant Eli Lilly after a couple of promising clinical trials showed that it helped a significant number of people with severe alopecia areata to regrow their hair. 

In one of the trials, 22 percent of the 184 patients who received 2 milligrams of Olumiant, and 35 percent of the 281 patients who received 4 milligrams, saw adequate scalp hair coverage, compared to 5 percent of the patients who received a placebo. 

In a second trial, 17 percent of 157 patients who received 2 milligrams, and 32 percent of 234 patients who received 4 milligrams, had adequate scalp coverage.

Some mild side effects were noted in the trials – including upper respiratory tract infections, headache, acne, and high cholesterol – but the treatment was ultimately deemed safe and effective.


It’s estimated that over 6.8 million people living in the US have alopecia areata. It can affect people of all ages, sexes, and all ethnic groups. While the condition has few physically harmful effects, it’s known to have a profound impact on some people’s mental wellbeing, having strong links to a higher risk of anxiety and depression.

Despite the huge toll the condition can have, this is the first drug to treat alopecia areata that’s ever been approved by the FDA. 

“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” Kendall Marcus, director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”

This isn’t the only use of baricitinib, however. The FDA has previously given approval to the drug as a second-line therapy for rheumatoid arthritis, an autoimmune disorder that primarily affects the joints of the body.  In May 2022, it was also given approval for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen.


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