FDA Approves Ritlecitinib For Severe Alopecia Areata

Pfizer announced that the US Food and Drug Administration (FDA) recently approved ritlecitinib (Litfulo) for individuals aged 12 and over with severe alopecia areata.¹ The once daily oral treatment is the first and only FDA approved treatment for adolescents with severe alopecia areata.

meyer_solutions/AdobeStock

Ritlecitinib is a kinase inhibitor that inhibits Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases. The approved recommended dose for ritlecitinib is 50 mg a day.

The newly approved treatment is particularly important for young people, as hair loss is such a visible disease.

“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) in a press release. “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.”

The FDA approval was based on clinical trials at 118 sites in 18 countries. The ALLEGRO Phase 2b/3 trial, which included 718 individuals with 50% or more scalp hair loss as measured by the Severity of Alopecia Tool (SALT), evaluated the efficacy and safety of ritlecitinib. After 6 months, 23% of participants treated with ritlecitinib had 80% or more scalp hair coverage (SALT ≤20) compared with 1.6% of the placebo group.

Participants in the randomized, placebo-controlled, double-blind trial received once-daily ritlecitinib at either 50 mg, 30 mg, or 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, groups treated with ritlecitinib continued with their assigned dose and those participants on the placebo switched to ritlecitinib, either 50 mg or 200 mg loading dose + 50 mg, for the remaining 24 weeks.

Pfizer said ritlecitinib will be available in the coming weeks. Click here for full prescribing information.

Reference

1. FDA approves Pfizer’s LITFULO™(Ritlecitinib) for adults and adolescents with severe alopecia areata. News Release: businesswire. June 23, 2023. Accessed June 26, 2023. https://www.businesswire.com/news/home/20230623087591/en/FDA-Approves-Pfizer%E2%80%99s-LITFULO%E2%84%A2-Ritlecitinib-for-Adults-and-Adolescents-With-Severe-Alopecia-Areata