Overview
- Pfizer reported positive topline results from two large phase 3 TRANQUILLO trials, saying the drug produced significantly higher rates of at least 75% facial repigmentation and at least 50% total-body repigmentation versus placebo at 52 weeks.
- The trials enrolled about 2,174 patients across 50 mg and 100 mg once-daily doses, with one study including patients aged 12 and older and the other limited to adults.
- Pfizer said the safety profile in the vitiligo studies matched what was seen in prior alopecia areata trials and that no new safety signals were identified.
- The company intends to submit the phase 3 data to regulators globally to seek approval of the oral treatment for adults with nonsegmental vitiligo.
- Litfulo targets TEC family kinases and JAK3 to reduce the immune attack on pigment-producing cells, and if approved it would add the largest late-stage oral option for a disease that causes visible skin depigmentation and significant psychosocial burden.