US FDA Approves First Drug Treatment For Severe Alopecia

The United States Food and Drug Administration (FDA) approved Monday Olumiant (baricitinib) oral tablets, the first pill to treat severe alopecia areata.

Olumiant, developed by the pharmaceutical company Eli Lilly, prevents the body’s immune system from attacking hair follicles. The drug was first approved in 2018 to treat rheumatoid arthritis. FDA also approved Olumiant to treat COVID-19 in some hospitalized adults.

“Today’s action marks the first FDA approval of a systemic treatment (i.e., treats the entire body rather than a specific location) for alopecia areata,” the FDA said in a statement.

Olumiant was tested among 1,200 adult patients with 50 percent scalp hair loss for over six months. During the trials, patients received a placebo, 2 milligrams, or 4 milligrams of Olumiant daily.

Results of the trial showed that 40 percent of patients who received 4 milligrams of Olumiant regrew their hair in 36 weeks. The same result occurred in 20 percent of patients who received 2 milligrams compared to the six percent of the people in the placebo group.

Despite the favorable results of the clinical trials, FDA warned about Olumiant’s side effects, such as upper respiratory tract infections, high cholesterol, urinary tract infection, and inflammation of hair follicles.

Alopecia areata is an autoimmune disorder affecting 300,000 people in the US annually.


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