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New Hair Loss Drug Approved by FDA for Alopecia Areata

A person holding a clump of hair.
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The hair loss drug LITFULO has been approved by the U.S. Food and Drug Administration (FDA) to treat alopecia areata, an autoimmune disease that causes hair loss on the scalp, face and body. The drug is approved in adults and adolescents aged 12 and over with severe alopecia areata, based on the results of a Phase 2b/3 clinical trial published in The Lancet.

Providing new treatment options for hair loss

Alopecia areata is caused by the immune system attacking the body’s hair follicles, leading to hair loss. It often occurs on the scalp, but can affect other areas such as the eyebrows, eyelashes and facial hair.

Hair loss is often patchy, but in some cases, all the hair on the scalp can be lost (known as alopecia totalis) or indeed all the hair on the body (known as alopecia universalis).

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Almost 7 million people in the U.S. and approximately 160 million globally are affected by alopecia areata, which occurs regardless of age, gender, race or ethnicity. Though the condition has few implications for physical health, it can have strong psychological and social consequences anxiety and depression are common in alopecia areata patients.

Now, this Pfizer-funded clinical trial has led to the approval of LITFULO (also known as ritlecitinib) for severe alopecia areata. It is the first and only treatment approved by the FDA to treat adolescents 12 years of age and older.

“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 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.”

Significant increases in hair coverage

LITFULO inhibits two types of enzymes, called kinases – these are Janus kinase 3 (JAK3), and TEC family tyrosine kinases. Inhibiting these enzymes is thought to block inflammatory signaling and cell-killing activity from T cells, a type of immune cell, which have been implicated in the development of alopecia areata.

The randomized, placebo-controlled and double-blind Phase 2b/3 clinical trial – named ALLEGRO – investigated the efficacy and safety of LITFULO.

Researchers recruited 718 volunteers with 50% or more hair loss on their scalp, as assessed by the Severity of Alopecia Tool (SALT), a widely used and validated assessment for measuring hair loss.

After 6 months of treatment, there was a statistically significant increase in hair coverage for those taking 50 mg of LITFULO compared to placebo – 29 (23%) of 124 participants who received 50 mg LITFULO had 80% or more hair coverage on their scalp by the end of the treatment period, compared to 2 (2%) of 130 participants in the placebo group.

The efficacy and safety of LITFULO were consistent between adolescents (12–17 years of age) and adults. The most common side effects reported in at least 4% of patients – included headache (10.8%), diarrhea (10%), acne (6.2%), rash (5.4%) and hives (4.6%). Based on these results, the FDA approved 50 mg LITFULO as the recommended dose.

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

“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.”

Reference: King B, Zhang X, Harcha WG, et al. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b–3 trial. The Lancet. 2023;401(10387):1518-1529. doi: 10.1016/S0140-6736(23)00222-2

This article is a rework of a press release issued by Pfizer Inc. Material has been edited for length and content.