Yesterday the FDA approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a disorder that often appears as patchy baldness and affects more than 300,000 people in the U.S. each year. It’s the first FDA approval of a systemic treatment (i.e. treats the entire body rather than a specific location) for alopecia areata.
“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, adding that the approval fulfills a significant unmet need for patients with severe alopecia areata.
Alopecia areata is an autoimmune disorder in which the body attacks its own hair follicles, causing hair to fall out, often in clumps. Manufactured by Eli Lilly and Company, Olumiant is a Janus kinase (JAK) inhibitor which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation.
Olumiant comes with a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis.
The full news release is available on FDA’s website.