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A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
GSK’s Priorix (measles, mumps and rubella vaccine, live) has been approved for active immunization for the prevention of measles, mumps and rubella (MMR) in individuals aged 12 months or older.
The efficacy of Priorix was demonstrated based on immunogenicity data versus the comparator vaccine, M-M-R-II, from two studies – Study 1, in children receiving Priorix as a first dose, and Study 2, in which Priorix was administered as a second dose.
Regeneron’s Dupixent (dupilumab; injection) has been granted a new indication for treating moderate-to-severe atopic dermatitis in children aged 6 months to 5 years whose disease is not adequately controlled with topical prescription therapies or for whom those therapies are not advisable.
Dupixent’s approval was based on findings from a Phase 3, double-blind, placebo-controlled trial in which 162 children from the indicated population were randomized to receive Dupixent plus standard-of-care topical corticosteroids (TCS) or TCS alone (placebo). At 16 weeks, 28% of patients receiving the Dupixent combination achieved clear or almost-clear skin, compared with 4% of placebo patients. In addition, 53% and 11% of patients, respectively, achieved improvement of 75% or more in overall disease severity from baseline, and 48% and 9% achieved clinically meaningful reduction in itch.
Dupixent received a priority review designation for this indication.
The monoclonal antibody was originally approved in 2017 for treating moderate-to-severe atopic dermatitis in adult and pediatric patients aged 6 and older. Most recently, it received a new indication for treating eosinophilic esophagitis in adults and pediatric patients aged 12 years or older, marking the first FDA approval of a treatment for the chronic inflammatory disorder. Dupixent is also approved as an add-on maintenance therapy for adults and pediatric patients aged 6 and older with certain types of moderate-to-severe asthma and for adults with inadequately controlled chronic rhinosinusitis with nasal polyposis.