The US Food and Drug Administration on Friday approved a treatment for alopecia for children, marking a historic first.
The drug, ritlecitinib, is a once-daily pill for children aged 12 and over with severe alopecia, a condition that develops when the body attacks hair follicles, causing hair loss.
The drug will be 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, a full year’s supply of Litfulo has a list price of $49,000, similar to other specialty dermatology treatments. The company said the actual cost to patients will vary based on individual health care plans.
“We are committed to helping patients access the treatments they need,” Pfizer said in a statement. “There will be copayment savings for commercially insured patients and a patient assistance program for eligible patients to achieve this. Through Pfizer’s Dermatology Patient Access Program, eligible patients will be able to get help accessing LITFULO. »
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, 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.
Her mother, Maryann Strattner, told ABC News that her daughter struggled both emotionally and physically with losing her hair. She said together they were determined to find a treatment that worked.
“As a parent, all you want for your child is to be happy and healthy. Period,” said Maryann Strattner. “So when you see your child come to you at 13 with no hair, you’re going to understand how you get their help.”
Maryann Strattner said her daughter found a clinical trial for ritlecitinib at Yale University in New Haven, Connecticut, and entered the trial in 2020.
A few months after taking the drug, Maria Strattner’s hair began to grow back, according to her mother, who said of her daughter’s perseverance, “Thank goodness that kid was smart enough not to give up.”
Maria Strattner previously had blonde hair, but her hair has grown back brown and in tighter waves, according to Maryann Strattner.
Dr. Brett King, associate professor of dermatology at the Yale School of Medicine and principal investigator of the ritlecitinib clinical trial, said this will happen in some cases with the drug, where a person’s hair grows back differently.
He described the FDA approval of ritlecitinib as a “tremendous advance” in the treatment of alopecia, describing the drug’s effect as “nothing short of transformative.”
“Within 24 weeks of treatment, about 30% of people in the trials grew their hair back. Remember, these are patients who initially had 50% to 100% hair loss from the scalp. they had no 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 up to 48 weeks that number jumps to 40% of people achieving dramatic hair regrowth.”
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King pointed out that ritlecitinib is considered a treatment for alopecia, not a cure. He said it is expected that patients will need to continue taking the drug long term in order to maintain hair growth.
Ritlecitinib is a type of drug known as a JAK inhibitor, a new type of drug that “interferes with signals in the body that are thought to cause inflammation,” according to the American Academy of Dermatology Association.
King noted that patients with a history of cancer, blood clots or cardiovascular disease should “review very carefully” their use of ritlecitinib.
“Ritlecitinib has warnings, like all drugs in its class, which is a class of drugs called JAK inhibitors,” King said. “These warnings, of course, should be heeded by everyone. And when we think about taking the drug…with careful thought and decision-making and consideration with patients, we can very well identify patients for whom this treatment is absolutely appropriate and safe.”
In addition to being approved for children 12 years and older, ritlecitinib is now also FDA approved for adults with alopecia areata.
Last year, the FDA also approved Olumiant, a once-daily pill for adults with alopecia areata.
What to know about alopecia
There are several types of alopecia, which is an umbrella term for hair loss.
While experts don’t fully understand the biochemical process for all of these conditions, they believe some types arise when a person’s immune system inappropriately targets their own hair follicles, which stifles hair growth, according to the National. Institutes of Health, while other types can be caused by genetics, hormones, or certain conditions like hypo or hyperthyroidism.
Experts believe that a combination of environmental and genetic factors may trigger the disease.
Alopecia areata is specifically the disease that develops when the body attacks the hair follicles, causing hair loss. Some of the subtypes include alopecia universalis, alopecia totalis, and alopecia patche, according to the AADA.
Alopecia universalis, a complete loss of all body, facial, and scalp hair, is considered the most extreme and rare form of the disease, according to the NIH.
Alopecia totalis, which is characterized by the loss of hair only from the scalp, is a less advanced form of the disease.
Patchy alopecia causes small, circular, patchy bald spots to develop, usually on the scalp and face.
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It is the most common type of alopecia areata, according to the NIH.
Alopecia areata affects nearly 2 percent of the general population at some point in their lives, or nearly 7 million people in the United States, according to the National Alopecia Areata Foundation, a California-based nonprofit organization.
The condition affects men and women equally and affects all racial and ethnic groups, according to the NIH.
Most people with alopecia areata are affected in their teens, 20s, or 30s, but it can occur at any age, according to the NIH.