A new treatment for severe alopecia got the Food and Drug Administration’s stamp of approval on June 23. The drug, which is called Litfulo (with the generic name ritlecitinib), is the first and only FDA-approved alopecia drug for kids 12 and up, in addition to adults.
Alopecia areata is a disorder in which the immune system attacks hair follicles, causing serious hair loss. This autoimmune disease often develops in young people, typically between their teens and 30s, according to the National Institutes of Health. It affects about 2% of the world’s population, and, in the US alone, approximately 6.7 million people, or one in every 500 to 1,000 with alopecia areata. Until now, we haven’t had a drug for adolescents, and there was only one approved treatment option for adults with a severe form of the condition.
Many people with alopecia develop circular bald patches on their scalps, though it can also lead to hair loss on the arms, legs, eyebrows, and eyelashes—really, anywhere on the body, per the US National Library of Medicine.
This can have a massive effect on a person’s quality of life, especially when it causes them to feel self-conscious and embarrassed about their appearance. Adolescents, in particular, are often excluded, teased, and bullied by their peers due to their hair loss. People with alopecia commonly report feeling frustrated about the lack of treatment options. Many have resorted to taking off-label therapies, like topical steroids, with varying results, and which can come with potential side effects, including acne and glucose intolerance.
Litfulo may very well change that for at least some people with alopecia areata. According to Pfizer, the drug’s manufacturer, it’s specifically designed for severe cases—or those who’ve lost 50% of the hair on their scalps due to the disease. And clinical trials show that it can work well—really well. In Pfizer’s study, 718 people took the drug, administered via a pill, once a day at a 10-, 30-, or 50-milligram dose for 24 weeks, after previously taking either a 200-mg daily dose or a placebo pill for 24 weeks. After five and a half months, up to 31% of people who started with a minimum of 50% hair loss and received the 50-milligram dose (following a month of taking 200 mg a day, rather than the placebo) had improved to 20% hair loss, or 80% or more scalp coverage.
As the study went on through 48 weeks, the number of people experiencing significant hair regrowth continued to increase. Some people’s eyebrows and eyelashes grew back, and other participants who were nearly bald due to the disease grew full heads of hair.
Pfizer expects Litfulo will be available in a few weeks. A big thing to note: It’s far from cheap—a year’s supply is priced at $49,000—but the out-of-pocket cost will vary depending on the type of health insurance you may have, a Pfizer spokesperson tells SELF.
Here’s how the drug works, and why some dermatologists are saying it’s a quantum leap for people with alopecia areata.
Litfulo stimulates hair growth by quieting part of the immune system.
You have about 5 million hair follicles on your body, and more than 100,000 of them, on average, are located on your scalp. At any given time, 90% of the follicles on your head are growing while the other 10% are in a resting phase where new hairs aren’t sprouting, Anthony Oro, MD, PhD, the Eugene and Gloria Bauer Professor of Dermatology at Stanford Health Care, tells SELF. Throughout your life, your hair goes through this growth cycle every two to six years (which is why some people are able to grow their hair all the way down to their waist).
This entire hair growth process is usually undetectable to the immune system, but with alopecia areata, the immune system picks up on this cycle and mistakenly attacks the follicles. “It essentially sends these signals that put the hair growth stem cells to sleep and they don’t wake up,” says Dr. Oro. The follicles are there, ready to grow, but the immune system goes haywire and prevents those follicles from doing their job. The hair then falls out.
This is where treatment might help. Litfulo targets the Janus kinases (JAK) pathway, the arm of the immune system that’s believed to play a major role in hair loss in people with alopecia. Scientists have been exploring the JAK pathway’s effects on hair in mice and humans for the past 10 to 12 years, says Dr. Oro, and have discovered that, by inhibiting the pathway, drugs like Litfulo (known as JAK inhibitors) can stimulate hair regrowth.
Like any medication, Litfulo has a few potential side effects: It can increase your risk of contracting infections, including upper respiratory infections and tuberculosis, and some people may get headaches, feel dizzy, or develop folliculitis (where your follicles become itchy and inflamed). You can check out the prescribing info here. Overall, like other JAK inhibitors, the drug is safe and well-tolerated, says Dr. Oro.
Litfulo is a potential game changer for young people with alopecia.
JAK inhibitors aren’t new. The first ones came out in 2011 and 2012, and health care providers have been prescribing these medications to people with alopecia off-label (a legal process in which a medication is used for purposes it wasn’t officially approved for) for years, says Dr. Oro. It wasn’t until 2022 that the FDA officially greenlighted one of these drugs—baricitinib, a.k.a. Olumiant—specifically for adults with alopecia. Like Litfulo, Olumiant led to 80% scalp coverage in some people with a severe form of the disease.
One thing to note: JAK inhibitors, including Litfulo, don’t cure alopecia. “Often, when you stop the medicine, in most cases, the hair loss will return,” says Dr. Oro—but the drugs can prevent the immune system from going after your hair follicles as long as you continue to take them.
As is the case with all new drugs, more data is needed to understand how Litfulo’s efficacy stacks up to other JAK inhibitors. Clinical trials contain a finite number of people, so until many more people are taking the drug and researchers can see its full effects, we won’t really know how it compares to, say, Olumiant, says Dr. Oro.
Here’s what we do know: Litfulo has the potential to help many people with alopecia grow hair again—especially those on the younger side! Hopefully, it’ll allow them to feel more confident and self-assured.
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