Pfizer's Litfulo meets Phase 3 endpoints for vitiligo treatment

Pfizer (NYSE: PFE) presented results from two Phase 3 trials showing that its drug Litfulo (ritlecitinib) met co-primary endpoints for the treatment of nonsegmental vitiligo, according to a company press release. The data were presented at the 35th European Academy of Dermatology and Venereology Annual Congress in Vienna, Austria.

In the TRANQUILLO 2 trial, which evaluated a 100 mg daily dose in 1,567 adults, 21.86% of patients achieved at least 75% improvement in the Facial Vitiligo Area Scoring Index (F-VASI75) compared with 2.40% on placebo. For total body repigmentation, 13.02% of patients on Litfulo achieved at least 50% improvement in the Total Vitiligo Area Scoring Index (T-VASI50) versus 2.40% on placebo.

In the TRANQUILLO trial, evaluating a 50 mg dose in 607 patients aged 12 and older, 12.47% achieved F-VASI75 versus 2.48% on placebo, and 8.98% achieved T-VASI50 versus 1.98% on placebo.

Improvements were observed as early as Week 24 and continued through Week 52. The two studies together enrolled 2,174 patients across 271 sites worldwide.

The safety profile was described as consistent with Litfulo's established profile in alopecia areata, with no new safety signals observed. Treatment-emergent adverse events were reported in 67.7% of patients on the 100 mg dose versus 62.0% on placebo in TRANQUILLO 2, and in 81.0% versus 77.1% in TRANQUILLO. Serious adverse events were reported in a low proportion of patients across both studies.

Pfizer said it intends to submit the data to regulatory authorities globally, including the U.S. Food and Drug Administration and the European Medicines Agency. Litfulo is currently approved in the U.S. for severe alopecia areata in adults and adolescents 12 years and older, but is not yet approved for vitiligo.

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