FDA announced on Monday that it has approved baricitinib, a drug manufactured by Eli Lily it has been shown to restore hair growth in patients with alopecia, marking the first systemic treatment for the disease.
Baricitinib, branded 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”, according to the FDA.
The drug has been studied in two trials, both published in the New England Journal of Medicine. In the first trial, 22% of the 184 participants who received two milligrams of baricitinib and 35% of those who received four milligrams had “adequate scalp coverage” after 36 weeks. Meanwhile, only 5% of the 189 patients who took a placebo saw their hair grow back.
In the second trial, 17% of 156 patients who received two milligrams of baricitinib and 32% of 234 patients who received four milligrams saw adequate scalp coverage after 36 weeks, compared with only 3% of 156 patients who took a placebo.
Patients in the trial experienced mild side effects, including a slight increased risk of acne, urinary tract infections and other infections. However, Olumiant, which is currently on the market as a treatment for rheumatoid arthritis and other autoimmune diseases, comes with a boxed warning for death, serious infection, major cardiovascular events and other side effects.
The approval of baricitinib marks the first systemic treatment on the market for alopecia, a disease that affects approximately 6.8 million people in the United States, the FDA said.
“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, director of the Division of Dermatology and Dentistry at the FDA. Center for Drug Evaluation and Research. “Today’s approval will help address a significant unmet need for patients with severe alopecia.”
In an editorial accompanying the trial results, Andrew Messenger of University of Sheffieldand Matthew Harries of University of Manchestersaid the trial results “are impressive” and that the results “represent the first published Phase 3 trials of a treatment for this disease.”
Severe hair loss not only ‘deprives a person of their identity’ but is also ‘a medical problem’, said Natasha Atanaskova Mesinkovska, scientific director at the National Alopecia Areata Foundation and Professor of Dermatology at University of California, Irvine. She added that when patients lose nose and ear hair, it can affect allergies and hearing.
Maryanne Makredes Senna, Director of Hair Loss Center of Excellence at Beth Israel Lahey Healthtried JAK inhibitors with his patients and said they had an “incredible impact” on his patients, which was “a beautiful thing to see”.
“They come in with no hair, totally withdrawing from life. Their eyes are downcast,” she said. “They come back and say, ‘I found my life. I found myself.'” (Kolata, New York Times, 6/13; Scriber, Axios, 6/13; bank head, MedPage today, 6/13; FDA press release, 6/13)