BRIEF—FDA and EMA accept Pfizer's filings for alopecia candidate ritlecitinib

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

The FDA 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).

Pfizer has also completed regulatory submissions for ritlecitinib in the UK, China and Japan, and expects decisions in 2023.

Eli Lilly and Incyte in 2021 claimed the first pivotal win for a JAK inhibitor in alopecia - Olumiant (baricitinib), which went on to win FDA approval in June this year.