FDA approves Pfizer’s Litfulo for patients with severe alopecia areata

Betsy Goodfellow | June 26, 2023 | News story | Medical Communications FDA, Litfulo, Pfizer, Pharmacy, alopecia, alopecia areata 

Pfizer has announced that the US Food and Drug Administration (FDA) has approved its Litfulo (ritlecitinib) for patients over the age of 12 with severe alopecia areata. The drug is a once-daily oral treatment, with an approved and recommended dose of 50mg. It is also the first and only FDA-approved treatment for adolescents with severe alopecia areata.

The drug is a kinase inhibitor which inhibits Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases. The approval of this drug follows results from the ALLEGRO phase 2b/3 clinical trial which enrolled 718 patients with 50% or more scalp hair loss. The trial found that 23% of patients treated with Litfulo has 80% or more scalp hair coverage after six months compared to hold 1.6% with placebo.

Dr Brittany Craiglow, associate professor adjunct of Dermatology at Yale School of Medicine, US, commented: “While patients may start to develop symptoms of alopecia areata at any age, most people start showing signs in their teens, twenties or thirties. Litfulo is a particularly important treatment option for younger patients with substantial hair loss, who often struggle with such a visible disease.”

Angela Hwang, chief commercial officer and president of Global Biopharmaceuticals Business at Pfizer, added: “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. With today’s approval, adolescents and adults who struggle with substantial hair loss have an opportunity to achieve significant scalp hair regrowth.”

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

Betsy Goodfellow

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