Following positive phase 3 trial results, Pfizer intends to submit global regulatory findings for Litfulo (ritlecitinib) as a potential therapy for nonsegmental vitiligo (NSV).
Litfulo received FDA approval to treat severe alopecia areata in 2023. Its unique mechanism of action targeting TEC family kinases and JAK3 has resulted in efficacy treating both active and stable NSV.
In two phase 3 clinical studies, 50 mg and 100 mg oral doses taken once daily led to statistically-significant and clinically-meaningful improvements compared to a placebo. The primary endpoints were improvements to facial and total body Vitiligo Area Scoring Index (VASI) from baseline to week 52. The drug already has a well-characterized safety profile, which was found to be consistent in NSV patients.