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FDA Approves First Pill To Treat Severe Alopecia

The FDA approved Olumiant (baricitinib), the first pill to treat severe alopecia areata. This decision is the first FDA approval of systemic treatment. Originally, Olumiant received approval in 2018. It was a treatment for certain adult patients with moderately severe active rheumatoid arthritis. Plus, it acted as a treatment for COVID-19 for certain hospitalized adults.

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

How Olumiant Helps with Alopecia Areata

Alopecia areata often appears as patchy baldness and affects more than 300,000 people in the U.S. annually. It is an autoimmune disorder in which the body attacks its hair follicles, causing hair to fall out, usually in clumps. Olumiant is a Janus kinase (JAK) inhibitor, which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation. During the Olumiant studies, patients who received dosages of Olumiant daily achieved adequate scalp coverage compared to those who didn’t.

Common Side Effects of Olumiant

Some of the most common side effects of the pill include the following:

  • Upper respiratory tract infections
  • Headaches
  • High cholesterol
  • Increase of Creatinine Phosphokinase
  • Urinary tract infection
  • Liver enzyme elevations
  • Folliculitis
  • Fatigue
  • Nausea
  • Genital yeast infections
  • Anemia

Lastly, Olumiant will come with a boxed warning for severe infection, mortality, and more. According to the FDA, individuals shouldn’t mix Olumiant with other JAK inhibitors or potent immunosuppressants. Furthermore, the FDA also advised any patient taking the drug should be closely monitored for infection during and after treatment.

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