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July 30 (Reuters) - Pfizer said on Thursday its oral drug helped restore skin color in patients with a common form of vitiligo in two late-stage trials, paving the way for regulatory submissions seeking approval in the autoimmune skin disease.
Here are the details:
• The U.S. drugmaker was testing Litfulo in patients with nonsegmental vitiligo, the most common type of the disease, which causes patches of skin to lose pigment.
• Pfizer 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.
• "Litfulo could become a new oral systemic treatment option for adults living with NSV, significantly improving and potentially maintaining facial and total body repigmentation," Michael Vincent, Pfizer's chief inflammation and immunology officer, said in a statement.
• The trials, which enrolled a combined 2,174 patients across 50 mg and 100 mg once-daily doses, were the largest late-stage programs to evaluate an oral treatment for nonsegmental vitiligo, the company said.
• The drug works by blocking specific proteins inside immune cells, called JAK3 and TEC family kinases, which helps stop 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, an autoimmune disorder that causes hair loss.
• Pfizer said the drug's safety profile in vitiligo patients was consistent with that seen in studies of alopecia areata, with no new safety signals identified.
• Pfizer plans to submit the data to health regulators globally to seek approval for the treatment in adults with nonsegmental vitiligo.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Vijay Kishore)
