Eli Lilly’s Olumiant (baricitinib) has been approved by the US Food and Drug Administration (FDA) for the treatment of alopecia areata (baldness). It became the first drug approved in the US for this indication. Olumiant was previously used to treat COVID-19.
The FDA’s decision is based on the results of two clinical trials showing that the 2 mg or 4 mg daily dose groups had significantly more participants with 80% scalp coverage by week 36 compared to placebo groups. The most common side effects associated with the use of Olumiant are upper respiratory infections, headache, acne, hyperlipidemia (high cholesterol), urinary tract infections, elevated liver enzymes, fatigue, nausea, anemia, and weight gain.
The first indication for which the FDA approved Olumiant (in 2018) was rheumatoid arthritis. In May 2022, the US regulator approved the use of the drug for the treatment of COVID-19 in hospitalized adult patients.
Alopecia is an autoimmune disease that results in hair loss. In the United States, this disease is diagnosed annually in more than 300 thousand citizens.