Approved: First Systemic Rx for Alopecia Areata

FDA approves Olumiant (baricitinib) oral tablets to treat alopecia areata

(RxWiki News) The US Food and Drug Administration (FDA) has approved a first-of-its-kind treatment for a type of alopecia.

The FDA approved Olumiant (baricitinib) oral tablets to treat alopecia areata, a disorder that affects an estimated 300,000 people in the United States every year.

Alopecia areata often appears as patchy bald spots on the head. While other treatments that target particular parts of the body have been approved to treat this disorder, Olumiant is the first that treats the whole body.

“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Dr. Kendall Marcus, director of the FDA's Division of Dermatology and Dentistry, in a press release. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”

Alopecia is a disorder that affects the body's autoimmune system. It causes the body to attack hair follicles, causing hair to fall out. According to the FDA, Olumiant blocks the activity of enzymes that are involved with inflammation, preventing hair loss.

Olumiant was tested for safety and effectiveness in two randomized and placebo-controlled trials. Each day, patients with alopecia were given either a placebo, a 2-milligram dose of Olumiant or a 4-mg dose.

After 36 weeks of treatment in one of the trials, only 3 percent of those who received the placebo had recovered at least 80 percent of their scalp hair coverage. For those who received 2 mg of Olumiant, that figure was 17 percent. And for those who received 4 mg, it was 32 percent. The results of the other trial were similar.

Side effects of Olumiant included headache, acne, upper respiratory tract infections, high cholesterol, urinary tract infections, problems with liver enzymes, tiredness, weight gain, hair follicle inflammation, anemia, shingles, stomach pain and yeast infections, among others.

This medication also includes a boxed warning — the most serious type of medication warning — about the risk of death, serious infections, major cardiac events, malignancy and thrombosis.

The FDA approved this drug for Eli Lilly and Company.

Talk to your health care provider about the medications available for your condition.

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Review Date: 
June 21, 2022