TUESDAY, June 14, 2022 — The first pill to treat adults with severe alopecia areata was approved by the U.S. Food and Drug Administration on Monday.
Olumiant (baricitinib) is the first FDA-approved alopecia therapy that treats the entire body rather than a specific spot, the agency said in a news release announcing the approval.
“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” Kendall Marcus, M.D., director of the Division of Dermatology and Dentistry in the FDA Center for Drug Evaluation and Research, said in the news release. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”
Olumiant is a Janus kinase (JAK) inhibitor that works by interfering with the cellular pathway that triggers inflammation. It was first approved in 2018 to treat rheumatoid arthritis, the FDA said.
The agency’s approval of the drug from Eli Lilly and Co. is based on two clinical trials that included 1,200 alopecia patients with at least 50 percent hair loss who took either 2 or 4 mg of Olumiant or a placebo every day. After 36 weeks, rates of patients who achieved at least 80 percent hair coverage were 17 and 22 percent for those who took 2 mg of Olumiant and 32 and 35 percent of those who took 4 mg of the drug. That compared with 3 and 5 percent of those who took a placebo, according to the FDA.
The most common side effects associated with Olumiant included upper respiratory tract infections, headache, acne, high cholesterol, increase of creatinine phosphokinase, urinary tract infection, liver enzyme elevations, inflammation of hair follicles, fatigue, lower respiratory tract infections, nausea, genital yeast infections, anemia, neutropenia, abdominal pain, shingles, and weight gain.
Olumiant should not be used in combination with other JAK inhibitors or any other potent immunosuppressants, the FDA warned. The drug carries a boxed warning for serious infections, death, cancer, major adverse cardiovascular events, and thrombosis. Patients taking the drug should be closely monitored for infection during and after treatment and should be checked for latent and active tuberculosis before treatment, the FDA advised.
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Posted June 2022