Alopecia areata is an autoimmune disease with an underlying immuno-inflammatory pathogenesis.
The FDA has accepted a New Drug Application (NDA) for ritlecitinib for patients 12 years and older with alopecia areata. In addition, the European Medicines Agency has accepted the marketing authorization for ritlecitinib in the same patient population.
Ritlecitinib is an experimental oral once-daily treatment that is the first in a new class of oral highly selective kinase inhibitors. This drug class is a dual inhibitor of the TEC group of tyrosine kinases and Janus kinase 3 (JAK3).
Alopecia areata is an autoimmune disease with an underlying immuno-inflammatory pathogenesis. The disease progresses when the immune system attacks the body’s hair follicles, causing hair loss. Hair loss can occur on the scalp, eyebrows, eyelashes, facial hair and other parts of the body.
“Alopecia areata is an autoimmune disease that can affect people of all ages, genders and ethnicities, often having an impact on daily life beyond the hair loss itself,” said Michael Corbo, PhD, chief development officer , Inflammation & Immunology, Pfizer Global Product Development, in a press release. “We believe that ritlecitinib, if approved, will be an important new treatment option, and we continue to work closely with regulatory authorities to bring ritlecitinib to adults and adolescents in the US and the EU.”
The randomized, double-blind ALLEGRO phase 2b/3 study investigated ritlecitinib in patients 12 years of age and older with alopecia areata. Each patient in the study had 50% or more scalp hair loss, according to the Severity of Alopecia Tool (SALT), which also included patients with alopecia totalis (complete hair loss on the scalp) and alopecia universalis (complete scalp, facial hair). and body). hair loss). The enrolled patients were in the midst of an episode of alopecia areata that lasted between 6 months and 10 years.
Patients were randomized to receive ritlecitinib 30 mg or 50 mg once daily with or without 1 month of initial treatment with ritlecitinib 200 mg, ritlecitinib 10 mg, or placebo once daily. The study showed statistically and significantly higher proportions of patients treated with ritlecitinib 30 mg and 50 mg (with or without loading dose) having 80% or more hair coverage after 6 months of treatment compared to placebo.
Ritlecitinib was well tolerated in both adult and adolescent patients. Adverse reactions (AEs) and severe AEs through Week 48 were experienced by 82% and 2% of patients, with similar rates in the active treatment groups. The most common adverse reactions were headache, nasopharyngitis and upper respiratory tract infections, and cases of herpes zoster, pulmonary embolism and breast cancer have been reported.
ALLEGRO-LT is an ongoing Phase 3 open-label, long-term study to further investigate the safety and efficacy of ritlecitinib in adults with alopecia areata with 25% or greater hair loss and adolescents 12 years of age and older with alopecia areata with 50% or greater hair loss .
FDA and EMA accept regulatory submissions for Pfizer’s ritlecitinib for individuals 12 years of age and older with alopecia areata. pfizer. September 9, 2022. Accessed September 13, 2022. https://www.pfizer.com/news/press-release/press-release-detail/fda-and-ema-accept-regulatory-submission-pfizers