hair-care

Litfulo becomes first FDA-approved treatment for adolescents with severe alopecia

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Key takeaways:

  • Litfulo is the first FDA-approved treatment for severe alopecia in patients aged as young as 12 years.
  • The approval was based on results from a phase 2b/3 trial recently published in The Lancet.

The FDA has approved Litfulo, a once-daily oral treatment, for the treatment of severe alopecia in individuals aged 12 years and older, Pfizer announced in a press release.

Litfulo (ritlecitinib), a selective dual Janus kinase 3 and tyrosine family kinase inhibitor, is now the first-ever FDA-approved treatment for severe alopecia in adolescents, according to the press release.

“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,” Angela Hwang, chief commercial officer and president of global biopharmaceuticals business at Pfizer, said in the release. “With today’s approval, adolescents and adults who struggle with substantial hair loss have an opportunity to achieve significant scalp hair regrowth.”

Data from ALLEGRO, a phase 2b/3 trial recently published in The Lancet, were used to support the approval.

Results from the study showed that 23% of patients treated with 50 mg of Litfulo achieved 80% or greater scalp hair coverage after 6 months of treatment, whereas 1.6% of placebo-treated patients achieved the same.

Litfulo exhibited similar efficacy and safety outcomes across all age groups. Most adverse events were well-tolerated by patients with the most common being headaches (10.8%), diarrhea (10%), acne (6.2%), rashes (5.4%) and urticaria (4.6%). Sixteen serious adverse events were reported in 14 patients; however, there were no major events or deaths.

According to the release, Litfulo will be available in the coming weeks.

Reference:

Perspective

Back to Top Maryanne Senna, MD)

Maryanne M. Senna, MD

For decades, when patients with severe alopecia areata sought treatment for their condition, the therapies available were either incredibly painful, led to significant long term side effects or were ineffective. Last year, our ability to care for this patient population was transformed with the first FDA approval of a JAK inhibitor for severe alopecia areata in adults. However, the adolescent and young adult alopecia areata population — one that is particularly affected by this chronic autoimmune hair loss condition — was still left without a favorable option.

Adolescence is a complex period of development and an important time of growth and discovery. As a dermatologist and hair loss specialist, I routinely witness the profound negative impact that severe alopecia can have on this patient population. Teens who were once successful students and athletes start avoiding school, sports practice and social activities. These adolescents commonly develop depression and anxiety, and many will experience bullying by their peers.

The FDA approval of ritlecitinib has paved the way for a brighter future for these patients. By successfully treating their alopecia, these adolescents and young adults are able to once again confidently navigate their lives, free from the burdens of stigma and chronic disease. By targeting underlying mechanisms of alopecia, this innovative therapy not only promotes hair regrowth but also effectively mitigates the emotional and social burdens associated with alopecia areata, empowering patients to realize their true potential.

Maryanne M. Senna, MD

Assistant Professor of Dermatology at Harvard Medical School Director of Lahey Hair Loss Center of Excellence at Lahey Hospital and Medical Center