The Food and Drug Administration on Monday approved a drug called baricitinib , made by U.S. pharmaceutical company Eli Lilly, with the trade name Olumiantas as the first for treating severe alopecia areata. “Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said FDA official Kendall Marcus in a statement. After 36 weeks, almost 40 percent of those on the higher dose grew back 80 percent of their scalp hair. The most common side effects included upper respiratory tract infections, headaches, acne, high cholesterol, and increase of an enzyme called creatine phosphokinase.
Baricitinib was previously approved for treatment of rheumatoid arthritis, and its license was extended to the treatment of hospitalized COVID patients. Alopecia affects more than 300,000 people in the U.S. every year. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata,” Kendall Marcus, the director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research, said in the release.
