Pfizer said a pair of late-stage studies of its Litfulo oral hair-loss drug met their key goals in the chronic depigmenting disorder nonsegmental vitiligo.
Pfizer on Thursday said the Phase 3 studies of Litfulo met their co-primary endpoints, with both the 50- and 100-milligram once-daily doses showing significant improvement in facial and total repigmentation versus placebo at 52 weeks in patients with both active and stable nonsegmental vitiligo who had a broad range of disease severity.
The New York drugmaker said that, based on the study results, it plans to submit global regulatory filings for Litfulo as a potential new oral systemic therapy for adults with nonsegmental vitiligo.
The U.S. Food and Drug Administration in 2023 approved Litfulo for the treatment of severe alopecia areata in people ages 12 and older.
Pfizer said it plans to launch a pivotal study evaluating Litfulo for the treatment of moderate alopecia areata this year.