USFDA accepts regulatory submission for Pfizer alopecia areata treatment Ritlecitinib
Alopecia areata is an autoimmune disease that has an underlying immuno-inflammatory pathogenesis and develops when the immune system attacks the body's hair follicles, causing hair to fall out.
New York: Pfizer Inc. has announced that the U.S. Food and Drug Administration (USFDA) has accepted for filing the New Drug Application (NDA) for ritlecitinib for adults and adolescents 12 years of age and older with alopecia areata.
The USFDA is expected to make a decision in the second-quarter 2023. The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for ritlecitinib in the same patient population with a decision anticipated in the fourth-quarter 2023.
Ritlecitinib is an investigational oral once daily treatment that is the first in a new class of oral highly selective kinase inhibitors that is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3 (JAK3).
Alopecia areata is an autoimmune disease that has an underlying immuno-inflammatory pathogenesis and develops when the immune system attacks the body's hair follicles, causing hair to fall out. This hair loss often occurs on the scalp, but it can also affect eyebrows, eyelashes, facial hair and other areas of the body. Alopecia areata affects approximately 6.8 million people in the U.S. and around 147 million people globally.
"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. "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 submissions were based on previously announced topline results from the pivotal and dose-ranging Phase 2b/3 ALLEGRO (NCT03732807) study and an ongoing Phase 3 ALLEGRO-LT (NCT04006457) open-label, long-term study. Results from the ALLEGRO Phase 2b/3 study were presented at the 2021 European Academy of Dermatology and Venereology (EADV) Congress and the 2022 American Academy of Dermatology Annual Meeting. Initial data from the ongoing ALLEGRO-LT study will be presented at the 2022 EADV Congress.
Pfizer has also completed regulatory submissions for ritlecitinib in the United Kingdom, China and Japan, and expects decisions in 2023.
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