Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved LITFULO™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. The approved recommended dose for LITFULO is 50 mg. It is the first and only treatment approved by the FDA for adolescents (12+) with severe alopecia areata.
"While patients may start to develop symptoms of alopecia areata at any age, most people start showing signs in their teens, twenties, or thirties," said Dr. Brittany Craiglow, Associate Professor Adjunct - 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."
LITFULO is a kinase inhibitor which inhibits Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases.
"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," said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer. "With today's approval, adolescents and adults who struggle with substantial hair loss have an opportunity to achieve significant scalp hair regrowth."
The FDA approval was based on results of clinical trials in alopecia areata. The ALLEGRO Phase 2b/3 trial, which enrolled 718 patients with 50% or more scalp hair loss as measured by the Severity of Alopecia Tool (SALT), evaluated the efficacy and safety of LITFULO at 118 sites 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. The efficacy and safety of LITFULO were consistent between adolescents (12 through 17 years of age) and adults (18 years of age and older). The most common adverse events (AEs) 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%). Full results from the ALLEGRO Phase 2b/3 study were published by The Lancet in April 2023.
"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 considerable negative impact beyond the physical symptoms," said Nicole Friedland, President and Chief Executive Officer of the National Alopecia Areata Foundation (NAAF). "We believe the approval of LITFULO is a significant advancement for the treatment of alopecia areata, particularly for teens. It's exciting to see more FDA-approved treatments becoming available for this community."
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LITFULO will be available in the coming weeks.
About Alopecia Areata
Alopecia areata is an autoimmune disease characterized by patchy or complete hair loss on the scalp, face, or body.1,2 It has an underlying immuno-inflammatory pathogenesis and develops when the immune system attacks the body's hair follicles, causing hair to fall out.1,2,3 This hair loss often occurs on the scalp, but it can also affect eyebrows, eyelashes, facial hair, and other areas of the body.1,2 Alopecia totalis (total scalp hair loss) and alopecia universalis (total body hair loss) are types of alopecia areata.1
Impacting nearly 7 million people in the U.S. and approximately 147 million people globally, alopecia areata can affect people of any age, gender, race, or ethnicity and can cause considerable burden beyond hair loss.1,2,3,4 Nearly 20% of people with alopecia areata are diagnosed before the age of 18.5
Additional Details on the ALLEGRO Clinical Trial Program
The randomized, placebo-controlled, double-blind ALLEGRO Phase 2b/3 trial (NCT03732807) investigated LITFULO in patients 12 years of age and older with alopecia areata. Patients included in the study had 50% or more scalp hair loss as measured by the Severity of Alopecia Tool (SALT), including patients with alopecia totalis and alopecia universalis, who were experiencing a current episode of alopecia areata that had lasted between six months and 10 years.
Patients were randomized to receive once-daily LITFULO (50 mg, 30 mg, 10 mg) with or without one month of initial treatment with once-daily LITFULO 200 mg, or placebo once-daily for 24 weeks. At Week 24, LITFULO groups continued their assigned doses and patients initially assigned to placebo switched to LITFULO (50 mg or 200 mg loading dose + 50 mg) for an additional 24 weeks.
In this pivotal study, a statistically significantly greater proportion of patients treated with LITFULO 50 mg had 80% or more scalp hair coverage (SALT≤20) after six months of treatment versus placebo (23% treated with LITFULO 50 mg compared to 1.6% with placebo).
The most common AEs occurring in at least 1% of patients through 24 weeks were headache, diarrhea, acne, rash, urticaria, 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.
