FDA Approves Olumiant, a New Drug to Treat Alopecia Areata

Olumiant (baricitinib)—a drug primarily used to treat rheumatoid arthritis and other autoimmune conditions—was approved Monday by the U.S. Food and Drug Administration (FDA) to regrow hair loss in patients with severe alopecia areata.

The oral drug, made by Eli Lilly, is the first systemic treatment (meaning it treats the whole body instead of one specific area) for the autoimmune skin disease.

"For the first time, we have really amazing data to support that [for] 40% or maybe more people who are suffering from severe alopecia areata, there's a treatment," lead study author Brett King, MD, associate professor of dermatology at Yale School of Medicine, told Health. "This is truly historic because prior to 2014, nobody thought that this disease could be treated effectively."

Alopecia areata occurs when the immune system attacks its own hair follicles, leading to patches of hair loss, usually on the scalp and face. In some cases, the hair loss is more severe and widespread. According to the National Organization for Rare Disorders, there are about 2.5 million people living with alopecia areata in the U.S. Until now, no other treatment has been specifically approved for the condition, though medications may be used off-label to treat it.

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

Here's what to know about Olumiant, including how it works and who it's meant for.

How Olumiant Works

Olumiant is a Janus kinase (JAK) inhibitor; it works by blocking activity in one or more of a specific family of enzymes, also known as Janus kinases. In patients with alopecia areata, JAK inhibitors silence the inflammatory chemicals produced around the hair follicle, allowing the inflammation to subside and the hair follicle to resume normal growth, Melanie Palm, MD, a board-certified dermatologist at Art of Skin MD, told Health.

FDA approval was based on the safety and efficacy of Olumiant in two phase 3 clinical trials, published in May in the New England Journal of Medicine. Across both trials, researchers looked at 1,200 adult patients with severe alopecia areata, defined as at least 50% scalp hair loss according to the Severity of Alopecia Tool. According to Dr. King, that means people who lost at least half or all of their scalp hair (alopecia universalis), for more than six months.

The patients were randomly assigned one of three options for treatment: a once-daily pill of 2 milligrams of Olumiant, 4 milligrams of Olumiant, or a placebo. Researchers measured success by how many patients saw at least 80% hair coverage on the scalp after 36 weeks of treatment.

About 39% of patients who received the 4-milligram dose of Olumiant in the first trial (BRAVE-AA1) saw complete or near-complete hair coverage after their 36 weeks of treatment; In the second trial (BRAVE-AA2), 36% of patients on the same dose saw the same results. Even patients who took the 2-milligram dose saw much better hair growth results as compared to placebo (23% vs. 6%; 19% vs. 3%).

"This is an incredible step forward in the path towards having an approved treatment that can help to alleviate the distress and suffering from patients with alopecia areata," study co-author Justin Ko, MD, a clinical professor of dermatology at Stanford Medicine, told Health. "In some patients for whom I have successfully treated, they note that in regrowing their hair, they feel like themselves again and that they have their life back."

Side effects associated with Olumiant were also mild or moderate in their severity, according to researchers. Acne was more common in patients who received baricitinib than with placebo, as were urinary tract infections. Other common side effects include: headaches, certain infections (upper and lower respiratory tract infections, yeast infections), and folliculitis (inflammation of hair follicles). The medication is also not recommended for use with other JAK inhibitors or types of immunosuppressants.

Other Treatments for Alopecia Areata

Olumiant is the first FDA-approved treatment for alopecia areata—specifically for use in severe disease. But some current treatments (though not FDA-approved), have been known to help people with more mild forms of the disease.

Corticosteroids—topical, intralesional and systemic—can be helpful in some patients, Brittany Craiglow, MD, an associate professor of dermatology at Yale School of Medicine, told Health. Other treatments, like immunotherapies or hair growth-stimulation solutions may also be helpful in milder cases.

"The more severe a patient is, the lower the chance of improvement with what we have in our toolbox now," said Dr. Craiglow. "Currently available therapies are not reliably effective, especially when people have more severe disease."

Two other pharmaceutical companies—Pfizer and Concert Pharmaceuticals—are also testing their own JAK inhibitors to treat alopecia areata.

Despite these promising treatments on (or soon-to-be) on the market, patients should still seek the advice of a dermatologist or other health care provider if they suspect they are dealing with any form of alopecia, Stephanie Travato, MD, a board-certified dermatologist and assistant professor of dermatology at the Ohio State University Wexner Medical Center, told Health.

Because alopecia areata severity differs between people, there are also varying treatment options—meaning, what may work for one person may not work for another. "The good news is that it is not a permanent form of hair loss," said Dr. Palm. "If we can quiet the noise around the hair follicle, the hair can regrow."

Though Olumiant is now FDA-approved, trials for the drug are still ongoing, according to researchers, and are intended to last for up to 200 weeks to see further safety and efficacy. But overall, Olumiant's FDA approval—and the promise of other drugs in the pipeline for alopecia areata—is promising to the community as a whole.

"It's awful to not know if you're going to wake up tomorrow missing an eyebrow. It's awful to not know if you're gonna wake up tomorrow and literally, your entire head of hair is going to be on the pillowcase," King said, adding that now having an available treatment is "unbelievably exciting."