Pfizer’s Litfulo “first and only” adolescent alopecia treatment approved by FDA

26 Jun 2023 --- The US FDA has approved Pfizer’s Litfulo (ritlecitinib), a once-daily oral treatment for severe alopecia areata in adults and adolescents. It is also the first treatment the agency authorizes for people over 12 and will be available in the coming weeks.

“While patients may start to develop symptoms of alopecia areata at any age, most people start showing signs in their teens, twenties or thirties,” says Dr. Brittany Craiglow, associate professor adjunct of dermatology at Yale School of Medicine.

“Litfulo is a particularly important treatment option for younger patients with substantial hair loss, who often struggle with such a visible disease.” The approved recommended dose for Litfulo is 50 mg.

Alopecia areata is an autoimmune disease resulting in patchy or complete hair loss on the scalp, face or body. Types of alopecia areata include the total loss of scalp hair (alopecia totalis) or total loss of body hair (alopecia universalis).

Growth opportunities
The prescription works by inhibiting Janus kinase 3 (JAK3) – which plays a role in the growth and development of immune system cells and blood cells. Litfulo also inhibits the “tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases.”The approved recommended dose for Litfulo is 50 mg per day.

According to the National Cancer Institute, tyrosine kinases are a part of cell functions, such as signaling, growth and division.

“Litfulo is an important treatment advancement for alopecia areata, an autoimmune disease that previously had no FDA-approved options for adolescents and limited options available for adults,” says Angela Hwang, chief commercial officer and president at Pfizer. 

“With today’s approval, adolescents and adults who struggle with substantial hair loss have an opportunity to achieve significant scalp hair regrowth.”

Study success and side effects
The FDA approved Litfulo based on the clinical trials of the drug. The trial enrolled 718 patients with 50% or more scalp hair loss as measured by the Severity of Alopecia Tool (SALT). Litfulo was evaluated at 118 sites and in 18 countries.

“In this pivotal study, 23% of patients treated with Litfulo 50 mg had 80% or more scalp hair coverage (SALT≤20) after six months compared to 1.6% with placebo,” shares Pfizer.

“The efficacy and safety of Litfulo were consistent between adolescents (12 through 17) and adults (18 and older). The most common adverse events reported in at least 4% of patients with Litfulo include headache (10.8%), diarrhea (10%), acne (6.2%), rash (5.4%) and urticaria (4.6%).”

Other reported adverse effects in at least 1% of patients through 24 weeks are “folliculitis, pyrexia, atopic dermatitis, dizziness, blood creatinine phosphokinase increase, herpes zoster, red blood cell count decrease and stomatitis. Cases of serious infection, malignancies, thromboembolic events and lab abnormalities were also reported.”

However, the study is ongoing in phase 3 with a long-term investigation on the safety and efficacy of Litfulo in adults with alopecia areata with at least 25% hair loss and in 12+ adolescents with 50% or greater hair loss.The trial enrolled 718 patients with 50% or more scalp hair loss.

More than “just hair”
Pfizer explains that alopecia areata is caused by immuno-inflammatory pathogenesis, which develops when the immune system attacks the body’s hair follicles, causing hair to fall out.

“People living with alopecia areata are often misunderstood, and their experience is frequently trivialized as ‘just hair.’ However, it is a serious autoimmune disease that can have a considerable negative impact beyond the physical symptoms,” comments Nicole Friedland, president and CEO at the National Alopecia Areata Foundation.

“We believe the approval of Litfulo is a significant advancement for treating alopecia areata, particularly for teens. It’s exciting to see more FDA-approved treatments becoming available for this community.”

Pfizer shares that the condition affects 7 million people in the US and around 147 million globally. “Nearly 20% of people with alopecia areata are diagnosed before age 18.5.”

Hair growth in the news
Last week, biopharmaceutical company Amplifica Holdings Group hinted that scientists at the University of California Irvine, US, found a molecule for treating hair loss. The company has prepared molecules for developing new hair growth solutions based on the finding.

We explored the latest hair loss solutions with personalized treatment plans, such as “human-to-human compatible” cell-based topical solutions and supplement launches targeting hair loss.

Chinese researchers used AI to predict compounds that could neutralize reactive oxygen species that cause balding on the scalp. A study revealed a potential answer to alopecia treatment could be a common arthritis drug.

Also, Gencor’s HairAge-Vitae was found to “considerably” increase hair density and decrease the hair loss ratio of patients with Alopecia.

By Venya Patel