The U.S. Food and Drug Administration on Friday approved a treatment for alopecia in children, marking a historic first.
The drug ritlecitinib is a once-daily pill for children 12 years and older with severe alopecia areata, a disease that occurs when the body attacks the hair follicles and causes hair loss.
The drug is sold under the brand name Litfulo and is manufactured by Pfizer.
Pfizer said Litfulo will be available to consumers “in the coming weeks.”
According to Pfizer, the list price for a year-round supply of Litfulo is $49,000, similar to other specialty dermatology treatments. The company said actual costs to patients will vary based on individual health plans.
“We are committed to providing patients with access to the treatments they need,” Pfizer said in a statement. “To achieve this, there will be copay savings for commercially insured patients and a patient assistance program for eligible patients. Eligible patients can receive assistance in accessing LITFULO through the Pfizer Dermatology Patient Access Program.”
The drug has already been a game changer for Maria Strattner, an 18-year-old with alopecia who participated in the clinical trial that led to FDA approval.
Maria Strattner, who hails from Danbury, Connecticut, was 13 when she lost all her hair — including her eyelashes and eyebrows — within two weeks and was diagnosed with severe alopecia areata.
Her mother, Maryann Strattner, told ABC News that her daughter is struggling with hair loss both emotionally and physically. She said that together they were determined to find an effective treatment.
“As a parent, you want your child to be happy and healthy. Period,” said Maryann Strattner. “So when you see your child come to you at 13 with no hair, you’ll figure out how you can help.”
Maryann Strattner said her daughter found a clinical trial for ritlecitinib at Yale University in New Haven, Connecticut, and enrolled in the study in 2020.
Within months of taking the drug, Maria Strattner’s hair began to grow back, according to her mother, who said of her daughter’s persistence, “Thank God the kid was smart enough not to give up.”
Maria Strattner previously had blonde hair, but according to Maryann Strattner, her hair grew back brown and in tighter waves.
dr Brett King, associate professor of dermatology at Yale School of Medicine and principal investigator on the ritlecitinib clinical trial, said that in some cases with the drug, this will happen if a person’s hair grows back differently.
He described the FDA’s approval of ritlecitinib as a “major advance” in the treatment of alopecia and described the drug’s effects as “downright transformative.”
“Over the course of 24 weeks of treatment, about 30% of the people taking part in the studies grew their hair back. Keep in mind that these are patients who initially had 50-100% hair loss on the scalp. A lot of times they didn’t have scalp hair,” King told ABC News. “And 24 weeks later, 30% of them have less than 20% [scalp hair loss] or complete scalp hair regrowth, and by 48 weeks that number rises to 40% of people achieving dramatic hair regrowth.”
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King emphasized that ritlecitinib is considered a treatment and not a cure for alopecia. He said it’s to be expected that patients would need to continue taking the medication long-term to maintain hair growth.
Ritlecitinib is a drug known as a JAK inhibitor, a new type of drug that “interferes with signals in the body thought to cause inflammation,” according to the American Academy of Dermatology Association.
King cautioned that patients with a history of cancer, blood clots, or cardiovascular disease should “evaluate very carefully” their use of ritlecitinib.
“Ritlecitinib has a warning, like all drugs in its class, which is a class of drugs called JAK inhibitors,” King said. “These warnings must of course be heeded by everyone. And when we think about taking the drug…with careful decision-making and consideration for the patient, we can very well identify patients for whom this treatment is entirely appropriate and safe.”
In addition to being approved for children ages 12 and older, ritlecitinib is now FDA approved for adults with alopecia areata.
Last year, the FDA also approved Olumiant, a once-daily pill for adults with alopecia areata.
What you should know about alopecia
There are several types of alopecia, which is a collective term for hair loss.
Although experts don’t fully understand the biochemical process of all of these disorders, they believe some types occur when a person’s immune system inappropriately targets their own hair follicles, suppressing hair growth, according to the National Institutes of Health, while other types of the disease do This case could be caused by genetics, hormones, or certain medical conditions such as hypo- or hyperthyroidism.
Experts believe that a combination of environmental and genetic factors can trigger the disease.
Alopecia areata in particular is the disease that results when the body attacks the hair follicles and causes hair loss. According to the AADA, subtypes include alopecia universalis, alopecia totalis, and patchy alopecia areata.
Alopecia universalis, a complete loss of all body, facial, and scalp hair, is considered the most extreme and rare form of the condition, according to the NIH.
Alopecia totalis, in which only hair on the scalp sheds, is a less advanced form of the condition.
Patchy alopecia areata causes small circular and patchy bald spots, usually on the scalp and face.
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According to the NIH, this is the most common form of alopecia areata.
According to the National Alopecia Areata Foundation, a California-based nonprofit organization, alopecia areata affects nearly 2% of the total population, or nearly 7 million people, in the United States at some point in their lives.
According to the NIH, the condition affects men and women equally and affects all racial and ethnic groups.
Most people who develop alopecia areata are affected in their teens, 20s, or 30s, but it can occur at any age, according to the NIH.