The U.S. Food and Drug Administration on Friday approved an alopecia treatment for kids, marking a historic first.
The drug, ritlecitinib, is a once-daily pill for kids ages 12 and older with severe alopecia areata, a disease that develops when the body attacks the hair follicles, causing hair loss.
The medication will be sold under the brand name Litfulo, and is manufactured by Pfizer.
Pfizer said Litfulo will be available for consumers “in the coming weeks.”
According to Pfizer, a full year supply of Litfulo has a list price of $49,000, similar to other specialty dermatologic 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 copay savings for commercially insured patients and a patient assistance program for eligible patients to help achieve this. Through the Pfizer Dermatology Patient Access Program, eligible patients will be able to get support with access to LITFULO.”
The medication has already been a game-changer for Maria Strattner, an 18-year-old with alopecia who took part in the clinical trial that led to the FDA’s approval.
Maria Strattner, who is from Danbury, Connecticut, was 13 years old when she lost all her hair — including her eyelashes and eyebrows — within a span of two weeks and was diagnosed with severe alopecia areata.
Her mom Maryann Strattner told ABC News her daughter struggled both emotionally and physically with the loss of her hair. She said that 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 figure out how you get her 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.
Within months of taking the medication, Maria Strattner’s hair started to regrow, according to her mom, who said of her daughter’s persistence, “Thank God that kid was smart enough not to give up.”
Maria Strattner previously had blonde hair, but her hair grew back brown and in tighter waves, according to Maryann Strattner.
Dr. Brett King, associate professor of dermatology at Yale School of Medicine and principal investigator of the clinical trial of ritlecitinib, said that will happen in some cases with the medication, where a person’s hair grows back differently.
He described the FDA’s approval of ritlecitinib as a “huge advancement” in the treatment of alopecia, describing the drug’s effect as “nothing short of transformative.”
“Over 24 weeks of treatment, about 30% of people participating in the trials regrew their hair. Remember, these are patients who at the start had 50% to 100% scalp hair loss. Often 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 rises to 40% of people achieving dramatic regrowth of hair.”King emphasized that ritlecitinib is considered a treatment for alopecia, not a cure. He said that it is expected that patients will need to continue on the medication on a long-term basis in order to maintain hair growth.
Ritlecitinib is a type of medication known as a JAK inhibitor, a new type of medication 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 would need to “very carefully consider” their use of ritlecitinib.
“Ritlecitinib has warnings, as do all medicines in its class, which is a class of medicines called JAK inhibitors,” King said. “These warnings, of course, must be considered in everybody. And when we think about taking the medicine … with careful decision making thought process and consideration with patients, we can identify very well patients for whom this treatment is absolutely appropriate and safe.”
In addition to being approved for kids ages 12 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 multiple types of alopecia, which is a blanket term for hair loss.
Although experts don’t fully understand the biochemical process of all these conditions, they believe some types occur 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 may be caused by genetics, hormones or certain illnesses like hypo- or hyperthyroidism.
Experts believe a combination of environmental and genetic factors can trigger the disease.
Alopecia areata specifically is the disease that develops when the body attacks the hair follicles, causing hair loss. Among the subtypes are alopecia universalis, alopecia totalis and patchy alopecia areata, according to the AADA.
Alopecia universalis, a complete loss of all body, face and scalp hair, is considered to be the most extreme and rarest form of the condition, according to the NIH.
Alopecia totalis, which is characterized by the loss of only hair on the scalp, is a less advanced form of the condition.
Patchy alopecia areata causes small circular and patchy bald spots to develop, usually on the scalp and face.
This is the most common type of alopecia areata, according to the NIH.
Alopecia areata affects nearly 2% of the general population at some point in their lifetime, 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 similarly and affects all racial and ethnic groups, according to the NIH.
Most people who get alopecia areata are affected during their teens, 20s or 30s, but it can occur at any age, the NIH states.
