The U.S. Food and Drug Administration on Monday approved the first treatment for severe alopecia, an autoimmune disorder that appears as patchy hair loss.
Baricitinib is produced by Eli Lilly under the brand Olumiant.
The FDA says alopecia areata affects millions of people around the world and annually more than 300,000 Americans.
Patients can have hair loss anywhere on their body,
Baricitinib, taken once a day, helps regrow hair by preventing the immune system from attacking hair follicles.
In clinical trials, sponsored by Ely Lilly, many patients who took the drug regrew much of their hair, the FDA says. The trials were published in the New England Journal of Medicine.
Among those affected by the alopecia are actor Jada Pinkett Smith and U.S. Rep. Ayanna Pressley.
The drug was originally approved by the FDA in 2018 to treat rheumatoid arthritis. Olumiant is also approved for the treatment of COVID-19 in certain hospitalized adults.
“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Dr. Kendall Marcus, 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.”
