FDA Approves Pfizer’s Ritlecitinib for Treatment of Alopecia Areata in Adolescents

The FDA has approved ritlecitinib (Litfulo; Pfizer Inc), a once daily oral treatment, for individuals aged 12 years and older with severe alopecia areata. This makes ritlecitinib, in the 50 mg dosage, the first and only treatment approved by the FDA for adolescents with severe alopecia areata.¹

“[Ritlecitinib] 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,” Angela Hwang, chief commercial officer and president of Global Biopharmaceuticals Business at Pfizer, said in a statement. “With today’s approval, adolescents and adults who struggle with substantial hair loss have an opportunity to achieve significant scalp hair regrowth.”¹

Ritlecitinib is a kinase inhibitor, affecting Janus kinase 3 and the tyrosine kinase expressed in the hepatocellular carcinoma kinase family.¹

The approval was based on the results of the ALLEGRO phase 2b/3 trial (NCT03732807), which included 718 individuals who had 50% or more scalp hair loss measured by the Severity of Alopecia Tool. Investigators of the study evaluated the safety and efficacy of ritlecitinib at 118 different sites in 18 different countries.¹

The results demonstrated that 23% of those treated with ritlecitinib had 80% or more scalp hair coverage after 6 months when compared with 1.6% of individuals receiving the placebo.¹

The efficacy and safety for those aged 12 years and older were consist with previously reported data. The most common adverse events with ritlecitinib included headache, diarrhea, acne, rash, and urticaria.¹

The full results from the ALLEGRO trial were published in The Lancet in April 2023.² Pfizer states that ritlecitinib will be available within the coming weeks.¹

“[Individuals] 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,” Nicole Friedland, president and CEO of the National Alopecia Areata Foundation, said in the statement. “We believe the approval of [ritlecitinib] 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.”¹

From 2016 to 2019, the prevalence and incidence of alopecia areata appeared to increase slightly in the United States, according to a study published in JAMA Dermatology. Furthermore, for those aged 12 to 17, the prevalence and incidence of alopecia areata seemed to increase and peak in young adulthood at age 18 through 44 years.³

Investigators found that the prevalence was higher in females regardless of the age group.³

According to the study, alopecia areata is characterized by nonscarring hair loss of the scalp, face, and/or body, with alopecia totalis being the complete loss of hair on the scalp and alopecia universalis being the complete loss of body hair.³

References

1. FDA approves Pfizer’s Litfulo (ritlecitinib) for adults and adolescents with severe alopecia areata. News release. June 23, 2023. Accessed June 26, 2023. https://www.pfizer.com/news/press-release/press-release-detail/fda-approves-pfizers-litfulotm-ritlecitinib-adults-and
2. King B, Zhang X, Harcha WG, Szepietowski JC, et al. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial. Lancet. 2023;401(10387):1518-1529. doi:10.1016/S0140-6736(23)00222-2
3. Mostaghimi A, Gao W, Ray M, Bartolome L, et al. Trends in prevalence and incidence of alopecia areata, alopecia totalis, and alopecia universalis among adults and children in a US employer-sponsored insured population. JAMA Dermatol. 2023;159(4):411-418. doi:10.1001/jamadermatol.2023.0002