Litfulo Approved for Severe Alopecia Areata in Adults, Adolescents

The Food and Drug Administration (FDA) has approved Litfulo^™ (ritlecitinib) for the treatment of severe alopecia areata in adults and adolescents 12 years and older.

Litfulo is an oral covalent kinase inhibitor with high selectivity for Janus kinase 3 (JAK3) and members of the tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family. The approval was based on data from the phase 2b/3 ALLEGRO trial (ClinicalTrials.gov Identifier: NCT03732807), which enrolled 718 patients 12 years of age and older with alopecia areata (≥50% scalp hair loss), including alopecia totalis and alopecia universalis.

Study participants were randomly assigned to receive ritlecitinib 30mg or 50mg (with or without 1 month of initial treatment with ritlecitinib 200mg once daily), ritlecitinib 10mg or placebo. The primary endpoint was the proportion of patients with scalp hair regrowth in response to ritlecitinib treatment, based on an absolute Severity of Alopecia Tool (SALT) score of 20 or less at week 24.

Compared with placebo, a greater proportion of patients who received ritlecitinib 50mg once daily (the recommended dose of Litfulo), had 20% or less scalp hair loss (an absolute SALT score ≤20) after 24 weeks of treatment (23% vs 1.6%; difference from placebo, 21.4 [95% CI, 13.4-29.5]). Efficacy was found to be consistent between adolescent and adult patients.

Additionally, 13.4% of patients treated with ritlecitinib 50mg had 10% or less scalp hair loss (SALT≤10) after 6 months compared with 1.5% with placebo (difference from placebo, 11.9 [95% CI, 5.4-18.3]).

The most common adverse reactions reported were headache, diarrhea, acne, rash, urticaria, folliculitis, pyrexia, atopic dermatitis, dizziness, increased blood creatine phosphokinase, herpes zoster, decreased red blood cell count, and stomatitis.

“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 have an opportunity to achieve significant scalp hair regrowth.”

Litfulo is supplied as a 50mg capsule. Treatment is administered orally once daily. Certain testing, evaluations, and immunizations are recommended prior to initiating therapy.

The prescribing information for Litfulo includes a Boxed Warning describing increased risks of serious infection, mortality, malignancy, major adverse cardiovascular events, and thrombosis related to JAK inhibitor use. Litfulo is not recommended for patients with severe hepatic impairment. It is also not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.

The product is expected to be available in the coming weeks.