FDA Approves Drug That Regrows Hair In Many Alopecia Patients

The Food and Drug Administration has approved a drug to treat people who have alopecia areata, an autoimmune disorder in which the body attacks hair follicles, causing baldness.

The drug, Olumiant, made by Eli Lilly and Company, is the first systemic, or full-body, treatment for alopecia. The drug has already been approved to treat other disorders, including rheumatoid arthritis.

Olumiant works by inhibiting certain enzymes to prevent the body from attacking the hair follicles, allowing the hair to regrow. Eli Lily said that two clinical trials found that one-third of the patients who were given a four-milligram dose of the drug regrew 80% of their hair within three months. Between 17% and 22% of patients who were given a smaller two-milligram dose also saw at least 80% of their hair grow back.

“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, M.D., 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.”