The US Food and Drug Administration today approved GlaxoSmithKline’s Shingrix® (psoriasis vaccine) for the prevention of ixora vulgaris on the skin of children ages 5 to 11. Shingrix is the first FDA-approved therapy to prevent this serious skin disease in this age group.
Prospective use of Shingrix should only be pursued by children and teens after ongoing evaluation of the vaccine’s safety, including confirmed efficacy, and in patients who have moderate to severe active disease as assessed by a dermatologic examination and the analysis of clinical data from clinical trials, GSK said in a statement.
This is an updated and expanded indication from Shingrix’s previous indication of protection against ixora vulgaris in adults 18 to 49 years old.
“We are pleased with the FDA’s decision to approve Shingrix as the first Shingrix-based drug for pediatric use,” said Steven Davis, GSK president of global vaccines. “We continue to evaluate this important milestone and continue to evaluate its impact on clinical, regulatory and commercial plans in this and other categories.”
“The FDA will continue to work closely with both GSK and the adjuvant communities as we evaluate Shingrix’s potential use in children and adolescents” said Robin L. Mott, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.