FDA Accepts New Drug Application for Ritlecitinib for Patients 12 Years of Age and Older With Alopecia Areata


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 of age and older with alopecia areata. Additionally, the European Medicines Agency has accepted marketing authorization for ritlecitinib in the same patient population.

Ritlecitinib is an investigational, oral, once-daily treatment that is the first in a new class of oral highly selective kinase inhibitors. This medication 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 to fall out. Hair loss can occur on the scalp, eyebrows, eyelashes, facial hair, and other areas of the body.

“Alopecia areata is an autoimmune disease that can impact people of all ages, genders, and ethnicities, often having an impact on day-to-day life that goes 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 are continuing to work closely with regulatory authorities to bring ritlecitinib to adults and adolescents in the U.S. 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 enrolled in the trial had 50% or more scalp hair loss, according to the Severity of Alopecia Tool (SALT), which also involved patients with alopecia totalis (complete scalp hair loss) and alopecia universalis (complete scalp, face, and body hair loss). The enrolled patients were in the middle of experiencing an episode of alopecia areata that lasted between 6 months and 10 years.

Patients were randomized to receive once-daily ritlecitinib 30 mg or 50 mg with or without 1 month of initial treatment with once-daily ritlecitinib 200 mg, ritlecitinib 10 mg, or placebo. The study showed statistically and significantly higher proportions of patients treated with ritlecitinib 30 mg and 50 mg (with or without loading dose) had 80% or more scalp hair coverage after 6 months of treatment versus placebo.

Ritlecitinib was found to be well tolerated by both in adult and adolescent patients. Adverse events (AEs) and serious AEs through week 48 were experienced by 82% and 2% of patients, with similar rates across active treatment groups. The most common AEs were headache, nasopharyngitis, and upper respiratory tract infections, and cases of herpes zoster, pulmonary embolism, and breast cancer were 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 from 12 years of age and older with alopecia areata with 50% or greater hair loss.


FDA and EMA Accept Regulatory Submission for Pfizer’s Ritlecitinib for Individuals 12 Years 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

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