- The FDA approved the first systemic, or full-body, drug to treat the hair-loss condition alopecia.
- It interferes with the unwanted immune response, and had already been approved for other autoimmune conditions.
- In trials, a third of patients achieved 80% scalp coverage. Side effects include infections and nausea.
The first systemic treatment for alopecia areata was approved today by the US Food and Drug Administration.
Alopecia areata is an autoimmune disorder in which the body attacks hair follicles, leading to hair loss. The drug, Olumiant, works by interrupting some of the body's misguided messages.
The approval gives alopecia patients, for whom good treatment options are lacking, another option. While Olumiant has been approved since 2018 for conditions including rheumatoid arthritis, its use for alopecia has been off-label until now.
"Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia," Dr. Kendall Marcus, director of the Division of Dermatology and Dentistry in the FDA's Center for Drug Evaluation and Research, said in a press release. "Today's approval will help fulfill a significant unmet need for patients with severe alopecia areata."
About a third of patients in clinical trials regrew enough hair to cover 80% of their scalp
To test the drug, which is manufactured by Eli Lilly and Company, researchers recruited 855 participants who had lost at least half of their scalp hair. Across two clinical trials, some of the participants received two milligrams of Olumiant, some received four milligrams, and some received a placebo every day.
They didn't know which pill they were taking, nor did the study investigators — making it a rigorous study design.
After 36 weeks, the researchers found that about a third of patients who received the higher dose had regrown enough hair to cover at least 80% of their scalp. Only 17% to 22% on the lower dose had that result, and ony 3% to 5% of those on the placebo did.
The most common side effects included respiratory tract infections, headaches, acne, high cholesterol, fatigue, nausea, and weight gain.
Alopecia treatments are lacking
Alopecia is medically benign, but its mental-health consequences can be severe.
Research shows women with the condition are at risk of depression, anxiety, a poorer quality of life, negative body image, and "marked disturbances" in their social life, like missing school or work. A 12-year-old died by suicide earlier this year after being bullied about her baldness.
But there is no cure, nor ideal solutions. Steroids, whether in cream, shot, or pill form, are common treatments, but only work in some cases and come with side effects.
Another option involves using chemicals to trigger a painful allergic reaction on the scalp, which, in 40% of cases, counterintuitively stops the immune system from attacking hair follicles. The therapy needs to be done consistently, and isn't widely available, according to the National Alopecia Areata Foundation.
Many women find wearing a wig — which can come with its own expense and discomfort — is the best solution.
Olumiant tamps down the unwanted immune response
Olumiant (generic name: baricitinib) is among a class of drugs called JAK inhibitors.
They've traditionally been used in autoimmune conditions like rheumatoid arthritis to block the unwanted immune response. While they seem to be helpful for some alopecia patients, JAK inhibitors other than Olumiant — including Xeljanz (tofacitinib) — are still being studied and not yet FDA-approved for alopecia.
Last year, the FDA began requiring warning labels on JAK inhibitors due to their "increased risk of serious heart-related events, cancer, blood clots, and death." Smokers and people with heart conditions are most at risk.
Still, many patients find the benefits of alopecia treatments outweigh the risks, dermatologist and hair loss specialist Maryanne Senna previously told Insider's Andrea Michelson.
"When my patients and study subjects regrow their hair because of these treatments, I see their smiles return," she said. "They tell me, 'I feel like I have my life back, I feel like myself again.'"