EC approves Pfizer’s Litfulo for adolescents and adults with alopecia

Betsy Goodfellow | September 19, 2023 | News story | Medical Communications Dermatology, EC, Litfulo, alopecia 

Pfizer has announced that the European Commission (EC) has granted marketing authorisation to Litfulo (ritlecitinib) to treat adult and adolescent patients over the age of 12 with sever alopecia areata.

The once-daily oral capsule is the first drug to be approved by the EC for the treatment of patients as young as 12 with severe alopecia areata. The drug is also the first and only treatment to selectively inhibit Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases.

This approval follows a recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in July 2023. The US Food and Drug Administration (FDA) and Japanese Ministry of Health, Labour and Welfare (MHLW) in June 2023.

Angela Hwang, chief commercial officer and president of the Global Biopharmaceuticals Business at Pfizer, commented: “Today’s approval of Litfulo in Europe is an important milestone for patients as young as 12 years of age with substantial hair loss from alopecia areata, as they now have an opportunity to achieve significant hair regrowth. Previously, there were no treatment options approved by the EC for adolescents with severe alopecia areata, and Pfizer is proud to be bringing forward this new innovative medicine for patients living with the challenges brought by this autoimmune disease.”

Betsy Goodfellow

Related Content

Merck’s Keytruda approved by EC for gastric cancer

Merck (known as MSD outside of the US and Canada) has announced the approval of …

FDA approves Pfizer’s Litfulo for patients with severe alopecia areata

Pfizer has announced that the US Food and Drug Administration (FDA) has approved its Litfulo …


Samsung Bioepis & Biogen receive positive CHMP opinion for ranibizumab biosimilar

Samsung Bioepis and Biogen have announced that the EMA’s Committee for Medicinal Products for Human …

Latest content