FDA accepts filing of New Drug Application (NDA) for ritlecitinib for adults and adolescents 12 years of age and older with alopecia areata
Today we received the welcome news that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for ritlecitinib, a product of Pfizer Inc., 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 of 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 highly-selective kinase inhibitors that is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3 (JAK3). This exciting news comes 3 months after the news that the Oluminant™ was approved by the FDA for adults with (moderate to severe) alopecia areata. As Nicole Friedland, President and CEO of the National Alopecia Areata Foundation, said in June, “We anticipate more treatments to come, bringing additional choices to our community.”
You can view the Pfizer’s press release on Pfizer.com: https://www.pfizer.com/news/press-release/press-release-detail/fda-and-ema-accept-regulatory-submission-pfizers
The National Alopecia Areata Foundation (NAAF) supports research to find a cure or acceptable treatment for alopecia areata, supports those with the disease, and educates the public about alopecia areata. Alopecia areata is a common autoimmune disease affecting nearly 7 million Americans that results in total or partial loss of scalp and body hair. Founded in 1981 and headquartered in San Rafael, CA, NAAF is widely regarded as the largest alopecia areata advocacy organization in the US. NAAF connects with more than 73,000 members of the alopecia areata community, including patients, family members, healthcare providers, and researchers through its support programs, email newsletters, website, research summits, and annual patient conference. NAAF is a 501 (c) 3 nonprofit and a GuideStar Gold-Rated charity and meets the rigorous standards of the Better Business Bureau Wise Giving Alliance and the National Health Council.