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The FDA approved the Janus kinase (JAK) inhibitor baricitinib (Olumiant) as the first systemic treatment for alopecia areata.

The approval pertains to adults with severe alopecia areata, which affects more than 300,000 people in the U.S. each year. Prior to this approval, only topical therapies were available to treat the condition.

"Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia," said Kendall Marcus, MD, of the FDA Center for Drug Evaluation and Research, in a . "Today's approval will help fulfill a significant unmet need for patients with severe alopecia areata."

An autoimmune disorder, alopecia areata results from immune system dysfunction that destroys hair follicles and causes hair loss, often in clumps. Baricitinib blocks the activity of one or more enzymes, leading to inflammation that targets hair follicles.

Principal support for the approval came from two randomized, placebo-controlled clinical trials involving more than 1,000 patients who had lost at least 50% of their hair for more than 6 months. Patients received a placebo or a single dose of baricitinib daily, and the primary endpoint was the proportion of participants who achieved at least 80% scalp hair coverage after 36 weeks.

In one study, 22% and 35% of patients assigned to different doses of baricitinib met the response criteria as compared with 5% of patients randomized to placebo. In the second trial, a third of patients treated with baricitinib met response criteria versus 3% of the placebo group.

The most common side effects associated with baricitinib are respiratory infections, headache, acne, high cholesterol, elevated creatinine phosphokinase, urinary tract infection, elevated liver enzymes, folliculitis, fatigue, nausea, genital yeast infections, anemia, neutropenia, abdominal pain, shingles, and weight gain.

Baricitinib labeling includes a boxed warning about serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.

The drug is marketed by Eli Lilly and has existing approvals for and .

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