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First Systemic Treatment for Alopecia Areata is Approved by FDA

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Yesterday, the U.S. Food and Drug Administration (FDA) approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata. Alopecia is an autoimmune disorder that affects over 300,000 people in the United States yearly, a condition in which the body attacks its own hair follicles and causes hair to fall out, often resulting in patchy baldness. 

Yesterday’s development is significant because it’s the first FDA approval of a systemic treatment for the condition — which means the drug is treating the entire body, rather than just a specific location. Olumiant is a Janus kinase (JAK) inhibitor which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation.

Olumiant was originally approved in 2018 as a treatment for adult patients with moderate to severe rheumatoid arthritis. It’s also approved for the treatment of COVID-19 in certain hospitalized adults. FDA approval is important for insurance coverage of these costly drugs, which have a list price of nearly $2,500 a month.

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

Typically, alopecia is caused by genetic factors — but something called “traction alopecia” can be the result of repeated pulling on the hair; this can happen via seemingly harmless daily habits like putting your hair up in a ponytail or bun. These movements begin to weigh on your follicles over an extended period of time, eroding them in the process. COVID-19 infection has also been linked to both hair loss and alopecia.

Alopecia’s harsh effects were brought to public light last March at the Academy Awards ceremony, when actor Will Smith ran onstage to slap comedian Chris Rock for making a joke about his wife’s shaved head. Jada Pinkett Smith had been shaving her hair since 2021 due to alopecia areata. Despite the unpleasantness of the incident, Google searches for alopecia increased by an estimated 600 percent after it happened — meaning there was a probable increase in awareness of and education about the disorder, as well.

Until recently, there was no drug to make the hair of alopecia patients grow back. But Olumiant may restore hair growth in many, making this an exciting development for those who have suffered from the disorder.

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