Pfizer has announced that two late-stage trials showed that its oral drug Litfulo helped restore skin colour in patients with a common form of vitiligo, paving the way for regulatory submissions seeking approval in the autoimmune skin disease, reports Reuters.
The company was testing Litfulo in patients with non-segmental vitiligo, which causes patches of skin to lose pigment, and said both studies showed significantly more patients treated with the drug achieved at least a 75% improvement in facial repigmentation, and at least a 50% improvement in total-body repigmentation after 52 weeks, compared with those given placebo.
The trials, which enrolled a combined 2 174 patients across 50mg and 100mg once-daily doses, were the largest late-stage programmes to evaluate an oral treatment for non-segmental vitiligo, the company said.
The drug works by blocking specific proteins inside immune cells – JAK3 and TEC family kinases, which helps top the immune system from attacking the pigment-producing cells in the skin.
Litfulo is already approved in several countries, including the United States, for severe alopecia areata, the autoimmune disorder that causes hair loss.
Pfizer plans to submit the data to health regulators globally to seek approval for the treatment in adults with nonsegmental vitiligo.
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