FDA on Monday announced it has approved baricitinib, a drug made by Eli Lilly that's been shown to restore hair growth in alopecia patients, marking the first systemic treatment for the disease.

Details on the drug

Baricitinib, brand-named 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 FDA.

The drug was 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, just 5% of the 189 patients who took a placebo saw hair regrowth.

In the second trial, 17% of the 156 patients who receive two milligrams of baricitinib and 32% of the 234 patients who received four milligrams saw adequate scalp coverage after 36 weeks, compared with just 3% of the 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 mortality, serious infection, major cardiovascular events, and other side effects.

Reaction

The approval of baricitinib marks the first systemic treatment for alopecia on the market, a disease that affects around 6.8 million people in the United States, 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 FDA's Center for Drug Evaluation and Research. "Today's approval will help fulfill a significant unmet need for patients with severe alopecia areata."

In an editorial accompanying the trial results, Andrew Messenger from the University of Sheffield, and Matthew Harries from the University of Manchester, said the trial results "are impressive," and the findings "represent the first published phase 3 trials of any treatment for this condition."

Severe hair loss not only "robs a person of their identity" but is also "a medical issue," said Natasha Atanaskova Mesinkovska, chief scientific officer at the National Alopecia Areata Foundation and a dermatology professor at the University of California, Irvine. She added that when patients lose hair in their nose and ears, it can affect allergies and hearing.

Maryanne Makredes Senna, director of the Hair Loss Center of Excellence at Beth Israel Lahey Health, has tried JAK inhibitors with her patients and said they had "an amazing impact" on her patients which was "a beautiful thing to see."

"They come in with no hair, totally withdrawing from life. Their eyes are cast down," she said. "They come back and say, 'I have my life back. I have my self back.'" (Kolata, New York Times, 6/13; Scribner, Axios, 6/13; Bankhead, MedPage Today, 6/13; FDA release, 6/13)