FDA approves Litfulo, alopecia areata hair loss drug for teens 12+
Alison Lee felt a slight tug at the back of her head.
Her dark wig slipped off in an instant, exposing her hairless scalp to the shining sun, the cool breeze, and her entire third grade class at recess.
She grabbed her head and turned to see her classmate hanging the piece of hair in his hands.
Lee, now 1[ads1]7, remembers the incident as vividly as if it were yesterday. It’s one of the many memories surrounding her alopecia areata, an autoimmune disorder that started causing her hair to fall out at age 5.
“Having alopecia as a child is a unique experience as you grow up and are still trying to figure out who you are and establish different parts of your identity,” said the New York City native.
There have never been any real treatment options for children and teenagers with alopecia areata. But that is about to change as the Food and Drug Administration on Friday approved the first and only medication on the market for the skin disease available to Americans under 18.
“It’s really a game changer,” said Dr. Kristen I. Lo Sicco, associate professor of dermatology at NYU Langone Health, who is also Lee’s doctor. “It’s important for a child – especially as they develop – to have their self-esteem and regain their sense of self-confidence.”
New treatment for teenagers with alopecia
The FDA approved the once-daily pill called Litfulo, made by pharmaceutical giant Pfizer, for people 12 and older to treat severe alopecia areata, or at least 50% hair loss.
About 23% of patients regained 80% or more of scalp hair coverage after six months of treatment compared with just 1.6% of participants in the placebo group, according to trial results published by The Lancet in April. The most common side effects reported included headache, diarrhea, acne, rash, and urticaria, a skin rash defined by itchy, red, or skin-colored bumps.
The only other alopecia medicine on the market is Olumiant, which was originally approved for rheumatoid arthritis, but was approved for alopecia in adults in June 2022. It is important for alopecia-specific treatments to get official approval because they are more likely to be covered by insurance companies, Lo Sicco said.
FDA approval “will help substantiate alopecia areata as more than just something that’s cosmetic, which has been considered for years by insurance companies that may not want to cover the therapies,” she said.
Lack of coverage will certainly put the treatment out of reach for many Americans. A full year’s supply has a list price of $49,000, according to Pfizer. That falls in line with other dermatology treatments like Olumiant, which is more than $2,600 for a month’s supply of 2-milligram pills.
What is alopecia areata?
Alopecia is a medical term to describe general hair loss. The condition gained more awareness after Jada Pinkett Smith spoke about it on an episode of her Facebook show “Red Table Talk” last year, describing her experience with hair loss.
It is unclear whether Pinkett Smith has alopecia areata, which is a specific skin disorder that causes the body’s immune system to attack the hair follicles. It is characterized by circular patches of hair loss and can result in complete loss of scalp hair, eyebrows, eyelashes, facial hair and body hair.
Experts say alopecia areata is more common than people might think. It is estimated that approximately 1 in 1,000 American children are affected by the skin condition, studies show.
Alopecia areata behaves similarly in both adult and pediatric patients, Lo Sicco said. But with children and teenagers, the social and emotional consequences of alopecia can also affect caregivers and other family members.
“It goes beyond the patients themselves … Some parents feel guilty because they feel like it’s their fault and it’s not,” she said. “Hopefully (this drug) will help families and parents have an improved quality of life as well.”
Other treatments for alopecia patients
Before Litfulo and Olumiant, no drugs were specifically approved by the FDA for alopecia areata. The traditional treatment has been monthly steroid injections. Studies have shown that in most cases people regain some of their hair, but the gains are usually lost if patients discontinue treatment, as many do because the shots directly into bald spots are painful.
Patients with extensive hair loss have also been given off-label immunosuppressants, experts say, but the treatment is not very effective and often comes with many side effects.
For pediatric patients, the choices are more limited because children generally hate shots and some parents feel uncomfortable giving their children immunosuppressive drugs, Lo Sicco said.
“Anyone struggling with hair loss deserves the choice”
Lee wants to be a role model for her younger sister Madeline, 13, who also has alopecia areata.
One of the most important things she’s tried to teach Maddy is to “look for a way to find joy in having alopecia,” whether it’s through cosmetics, hats or other means of expression.
“One of the great things about having alopecia is that you have so much freedom in how you can choose to express yourself,” Lee said.
She has also founded the Alopecia Justice League with Lo Sicco, her mother Julie Yoo and others affected by the skin condition. The organization is behind the legislative battle to have cranial prostheses, commonly known as wigs, covered by Medicare.
Lee hopes her efforts create a better future for her sister and other girls like her.
“My passion for spreading awareness about alopecia stems from the many years I have had to endure the consequences of the lack of awareness,” she said. “Anyone struggling with hair loss deserves the choice.”
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
