The FDA approves the first treatment that can regrow hair for teenagers with severe alopecia areata

The US Food and Drug Administration on Friday approved an alopecia treatment for children, marking a historic first.

The drug, ritlecitinib, is a once-daily pill for children age 12 and older with severe alopecia areata, a disease that develops when the body attacks the hair follicles, causing hair loss.

The medicine 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, comparable to other specialty dermatology treatments. The company said actual costs to patients will vary based on individual health plans.

“We are committed to helping patients access the treatments they need,”[ads1]; Pfizer said in a statement. “There will be cost 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 be supported with access to 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, who is from Danbury, Connecticut, was 13 years old when she lost all her hair – including eyelashes and eyebrows – within two weeks and was diagnosed with severe alopecia areata.

Her mother Maryann Strattner told ABC News that 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 1 p.m. with no hair, you’re going to figure out how to get help from her.”

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 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 used to have 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 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’s approval of ritlecitinib as a “major advance” in the treatment of alopecia, and described the drug’s effect as “nothing short of transformative.”

“Within 24 weeks of treatment, about 30% of the people in the trials have regrowed their hair. Remember, these are patients who initially 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 regrowth of scalp hair, and up to 48 weeks this number rises to 40% of people achieving dramatic hair regrowth.”

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King stressed that ritlecitinib is considered a treatment for alopecia, not a cure. He said it is expected that patients will need to continue the medication long-term to maintain hair growth.

Ritlecitinib is a type of medicine known as a JAK inhibitor, a new type of medicine that “disrupts 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 must “very carefully consider” the use of ritlecitinib.

“Ritlecitinib has caveats, like all drugs in its class, which is a class of drugs called JAK inhibitors,” King said. “These warnings must of course be taken into account in everyone. And when we think about taking the medicine … with careful decision-making thought process and assessment with patients, we can identify patients for whom this treatment is absolutely appropriate and safe. .”

In addition to being approved for children aged 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 you should know about alopecia

There are several types of alopecia, which is a general term for hair loss.

Although experts don’t fully understand the biochemical process behind all of these conditions, they believe that some types occur when a person’s immune system mistakenly targets their own hair follicles, stifling hair growth, according to the National Institutes of Health, while other types may be caused by of genetics, hormones or certain diseases such as hypo- or hyperthyroidism.

Experts believe a combination of environmental and genetic factors can trigger the disease.

Alopecia areata is specifically the disease that develops when the body attacks the hair follicles and causes 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 hair on the body, face and scalp, is considered the most extreme and rarest form of the condition, according to the NIH.

Alopecia totalis, which is characterized by loss of hair only 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.

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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 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 who get alopecia areata are affected in their teens, 20s or 30s, but it can occur at any age, says the NIH.