SILVER SPRING, Md. — For the first time, the U.S. Food and Drug Administration has approved a pill which can treat adults dealing with the hair loss disorder alopecia areata. The FDA says Olumiant (baricitinib) is the first drug to offer systemic treatment for the condition — meaning it treats the entire body instead of just one area.
The announcement on June 13, 2022 offers new hope for the more than 300,000 Americans who develop these bald patches each year.
“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” says Kendall Marcus, M.D., director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research, in a media release. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”
What is alopecia areata?
The condition, which most people just call alopecia, is actually an autoimmune disorder. In this case, the body attack its own hair follicles, causing them to fall out. Generally, this happens in clumps, leaving patients with large patches of missing hair. Actress Jada Pinkett Smith has become one of the most well-known people dealing with alopecia in recent years.
The new treatment, Olumiant, is a Janus kinase (JAK) inhibitor. This class of drug blocks the activity of one or multiple enzymes in a specific family — preventing them from causing inflammation.
Interestingly, the FDA already approved Olumiant for use in 2018 as a treatment for rheumatoid arthritis. More recently, doctors have been using the drug as a treatment for COVID-19 in certain hospitalized adults.
1 in 3 patients saw their hair grow back
In an attempt to repurpose the drug again, researchers tested Olumiant in two randomized, double-blind, placebo-controlled trials (Trial AA-1 and Trial AA-2) with hundreds of patients dealing with alopecia. Each volunteer lost at least 50 percent of their hair, according to the Severity of Alopecia Tool, and was living with the condition for more than six months.
The groups received either a placebo, two milligrams of Olumiant, or four milligrams of Olumiant daily throughout the trials. Researchers considered 80-percent hair coverage after 36 weeks a success.
In Trial AA-1, 22 percent of the 184 patients taking two milligrams of Olumiant reached that milestone. More than one in three (35%) of the 281 patients taking four milligrams of Olumiant also reached that mark.
In Trial AA-2, only 17 percent of the 156 patients taking two milligrams of Olumiant had a successful restoration. Meanwhile, 32 percent of the 234 patients receiving four milligrams of the drug saw their hair grow back.
Researchers note that taking Olumiant can cause side-effects, including upper respiratory tract infections, headache, acne, high cholesterol, and urinary tract infections. Patients may also experience an inflammation of hair follicles, fatigue, lower respiratory tract infections, nausea, genital yeast infections, anemia, abdominal pain, shingles, and weight increase.
The FDA is not recommending this treatment for patients already taking other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.