FDA approves alopecia drug that restores hair growth

The Food and Drug Administration approved a drug Monday that restores hair growth and can act as a treatment for alopecia areata.

Why it matters: This is the first systemic treatment for the disorder, which affects more than 300,000 people every year, the FDA said.

Alopecia is an autoimmune disorder in which the body attacks hair follicles, forcing large clumps of hair to fall out. About 6.8 million people in the United States currently have alopecia.

Details: The newly-approved drug — called Olumiant — is an oral tablet made by drugmaker Eli Lilly that regrows hair by stopping the immune system from attacking those follicles.

  • Olumiant was tested in two trials, which involved 1,200 patients with the condition.About 40% of patients who took the drug had total or nearly-complete hair regrowth after 36 weeks.
  • After one year, about half of the patients had all of their hair back.

By the numbers: In the first trial, 22% of 184 patients who received 2 milligrams of the drug and 35% of 281 patients who received 4 milligrams had “adequate scalp hair coverage,” according to the FDA.

  • The trial found that 5% of 189 patients who took a placebo had hair regrowth.
  • In the second trial, 17% of 156 patients who received 2 milligrams and 32% of 234 patients who received 4 milligrams had adequate scalp coverage.
  • Meanwhile, 3% of 156 patients who took a placebo in the second trial had adequate coverage.

Olumiant comes with some side effects and a boxed warning for mortality, serious infection and major cardiovascular events, among other potential issues.

What they’re saying: “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 division of dermatology and dentistry in the FDA’s Center for Drug Evaluation and Research, in a statement.

  • “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”

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