By Fineline Cube The Center for Drug Evaluation (CDE) website indicates that Pfizer’s (NYSE: PFE) category 1 drug ritlecitinib (PF-06651600) has obtained breakthrough therapy designation (BTD) status for use in moderate to severe active ulcerative colitis (UC) in adults.
Mechanism of Action
Ritlecitinib, a Janus kinase 3 (JAK3) inhibitor, selectively inhibits JAK isoenzymes through covalent interaction with the specific residue cys-909 of JAK3.
Clinical Progress
The drug has entered Phase III clinical trials for alopecia areata. It received BTD status in the US in September 2018 and was granted BTD by China’s CDE in December 2020.-Fineline Info & Tech