FDA approves first oral JAK inhibitor for treatment of alopecia areata in adolescents
USA: The US FDA (Food and Drug Administration) has approved ritlecitinib (Litfulo), a Janus kinase (JAK) inhibitor, for adults and adolescents with severe alopecia areata. The approved recommended dose for Litfulo is 50 mg.
Litfulo is a kinase inhibitor which inhibits Janus kinase 3 (JAK3) and the tyrosine kinase expressed in the hepatocellular carcinoma (TEC) family of kinases. Ritlecitinib also is being evaluated for vitiligo, ulcerative colitis, and Crohn's disease.
With this approval, Ritlecitinib becomes the second oral JAK inhibitor approved for alopecia areata and the first approved treatment for adolescents 12 years and older with this condition. The first FDA-approved JAK inhibitor for this hair loss condition is baricitinib (Olumiant). The approved recommended dose for Litfulo is 50 mg.
“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.”
The approval by the FDA was based on the phase IIb/III ALLEGRO trial, which involved 718 patients with 50% or more scalp hair loss as measured by the SALT (Severity of Alopecia Tool). In the trial, the researchers evaluated the safety and efficacy of Litfulo at 118 sites in 18 countries.
Key findings of the trial include:
- 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%).
The results from the trial were published in The Lancet.
“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 can 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 a 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 treating alopecia areata, particularly for teens. It’s exciting to see more FDA-approved treatments available for this community.”
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