Pfizer's oral drug restores skin pigmentation in late-stage vitiligo trials
Pfizer's oral drug restores skin pigmentation in late-stage vitiligo trials July 30 (Reuters) - Pfizer PFE.N 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)
((Kamal.Choudhury@thomsonreuters.com;))
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