First Systemic Treatment for Alopecia Areata Approved

The U.S. Food and Drug Administration approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata. This disorder often appears as patchy baldness and affects more than 300,000 people in the U.S. annually.

Announced on June 13, 2022, this is the first FDA approval for a medicine treating the entire body rather than a specific location for alopecia areata (AA).

Olumiant is a Janus kinase (JAK) inhibitor that blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation.

Olumiant is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.

The FDA initially approved Olumiant in 2018.

It is approved as a treatment for certain adult patients with moderately to severely active rheumatoid arthritis.

And recently, Olumiant was 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 AA,” commented Kendall Marcus, M.D., director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research, in a related press statement.

“Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”

Alopecia areata, commonly referred to as just alopecia, is an autoimmune disorder in which the body attacks its hair follicles, causing hair to fall out, often in clumps.

"Today marks a milestone with the first-ever FDA-approved systemic treatment for alopecia areata patients, who face significant challenges every day, including limited public knowledge about the disease, a lack of treatment options, and social stigma," said Nicole Friedland, president, and CEO, of National Alopecia Areata Foundation (NAAF), in a press release.

"The approval of OLUMIANT can spark hope for many patients and encourage new treatment conversations with their doctors."

"The NAAF wants more choices for our patient community, and with the approval of OLUMIANT, there are now new treatment expectations being established in alopecia areata care."

Olumiant comes with warnings and precautions, including recommending close monitoring for the development of signs and symptoms of infection during and after treatment; evaluating patients for active tuberculosis infection, and testing for latent tuberculosis before treatment with Olumiant; and the potential for viral reactivation.

In addition, other warnings and precautions include hypersensitivity, gastrointestinal perforations, and laboratory abnormalities, including low white and red blood cell counts, liver enzyme elevations, and lipid elevations.

Olumiant comes with a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.

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