FDA Approves Ritlecitinib for Ages 12 and Up for Alopecia Areata

The US Food and Drug Administration (FDA) today approved ritlecitinib for the treatment of severe alopecia areata in people ages 12 and older, the manufacturer announced.

Taken as a once-daily pill, ritlecitinib is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3 (JAK3). The recommended dose of ritlecitinib, which will be marketed as Litfulo, is 50 mg once a day, according to the statement announcing the approval from Pfizer.

It is the second JAK inhibitor approved for treating alopecia areata (AA) following approval last year in June of baricitinib (Olumiant), for alopecia areata in adults. Ritlecitinib is the first JAK inhibitor approved for children ages 12 and older with AA.  

The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application for ritlecitinib in the same population and a decision is expected in the fourth quarter of this year.

Source: MEDspace