FDA Approves First Systemic Alopecia Treatment

The U.S. Food and Drug Administration (FDA) has approved a new drug, Olumiant (baricitinib), to treat alopecia areata. The June 13 announcement stated that the new approval marked the first time the agency has approved a systemic treatment that targets the entire body rather than a single location.

Alopecia areata, sometimes shortened to just alopecia, is an autoimmune disorder that causes the body to attack its own hair follicles. This presents as hair falling out in clumps on the scalp, face, or other areas of the body and affects over 300,000 people each year, according to the FDA. The National Alopecia Areata Foundation states that Americans face a 2.1% lifetime risk of developing this condition regardless of age, biological sex, or race. For those living with alopecia, studies have found an increased risk of developing anxiety and depression, as well as reduced self-esteem.

Although some topical treatments are available to treat alopecia, Olumiant is the first systemic treatment approved for this autoimmune disorder. Dr. Kendall Marcus, M.D., director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research stated in the FDA announcement, “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.” Dr. Marcus added that safe and effective treatment of alopecia was “crucial” for those who live with the condition.

While alopecia can cause hair to fall out due to inflammation, the hair follicle actually continues to live. This means that if the underlying inflammation can be addressed, the hair can start to regrow. Olumiant accomplishes this by acting as a Janus kinase (JAK) inhibitor. A JAK inhibitor blocks the activity of certain enzyme families, causing interference along the pathways used to initiate the inflammation that leads to hair loss.

Olumiant, originally manufactured by Eli Lilly and Company in 2018 for rheumatoid arthritis, was approved after being studied in two randomized, double-blind, placebo-controlled trials that took place over the course of nine months. All patients in these two trials, Trial AA-1 and Trial AA-2, had 50% scalp hair loss as determined by the Severity of Alopecia Tool for more than six months and would receive either a placebo, 2-milligram dosage, or 4-milligram dosage of Olumiant. The benchmark for success was whether or not participants would achieve at least 80% scalp coverage after taking Olumiant daily for 36 weeks.

In the first trial, 22% of participants in the 2mg group and 35% of participants in the 4mg group had reached at least 80% hair coverage compared to only 5% of participants in the placebo group. In the second trial, the Olumiant group outperformed the placebo group with 17% of 2mg participants and 32% of 4mg participants reaching the success threshold compared to 3% of placebo participants.

In addition to demonstrating the efficacy of Olumiant, the trials also highlighted some of the risks. The most common side effects observed in the trials included:

  • Abdominal pain
  • Acne
  • Anemia
  • Fatigue
  • Genital yeast infections
  • Headache
  • High cholesterol
  • Increased levels of the enzyme creatinine phosphokinase
  • Increased liver enzyme levels
  • Inflammation of the hair follicles (folliculitis)
  • Low white blood cell levels (neutropenia)
  • Lower respiratory tract infections
  • Nausea
  • Shingles
  • Upper respiratory tract infections
  • Urinary tract infection
  • Weight gain

According to the FDA, Olumiant will feature a boxed warning for “serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis.” Olumiant also features a number of drugs not to be used with it, including immunosuppressants, other JAK inhibitors, and immunomodulators.

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