Pfizer has announced positive results from two phase 3 trials assessing Litfulo (ritlecitinib) as a once-daily oral treatment for nonsegmental vitiligo. The TRANQUILLO 2 and TRANQUILLO studies demonstrated significant improvements in facial and total body repigmentation compared to placebo. These findings were supported by patient-reported outcomes that showed reduced disease severity and enhanced stabilization. These results, derived from the largest phase 3 program to date for an oral systemic therapy in this condition, were presented at the 35th European Academy of Dermatology and Venereology Annual Congress in Vienna. The trials also evaluated long-term safety and tolerability, with no new safety signals identified.
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They involved patients with varying disease extents, with improvements in repigmentation observed over time. Both studies reported meaningful changes in facial and total body repigmentation, alongside greater disease stabilization versus placebo. Patient-reported outcomes confirmed these clinical benefits. These findings indicate a shift in how the condition affects daily life. Pfizer plans to submit the data to global regulatory bodies, including the U.S. FDA and the European Medicines Agency, for potential approval. The submission is expected to proceed in the coming months, with regulatory decisions anticipated later this year.
