U.S. FDA And European Medicines Agency Accepted Pfizer's Hair Loss Candidate Submission For Review

The U.S. Food and Drug Administration (FDA) has accepted for review Pfizer’s PFE New Drug Application (NDA) for ritlecitinib for adults and adolescents 12 years of age and older with alopecia areata.

The regulatory agency is expected to make a decision in the second-quarter of 2023.

The submission is based on top-line data readout from the pivotal and dose-ranging Phase 2b/3 ALLEGRO study and an ongoing Phase 3 ALLEGRO-LT open-label, long-term study.

Additionally, The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for ritlecitinib in the alopecia areata 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).

Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development, commented: "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. 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 company has also completed regulatory submissions for ritlecitinib in the United Kingdom, China and Japan, and expects decisions in 2023.

Price Action : Pfizer shares closed Thursday’s trading higher around 2 percent at $47.06