FDA grants priority review to Dupixent for atopic dermatitis patients 6 months to 5 years
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The FDA has accepted for priority review a supplemental biologics application for Dupixent that could allow treatment of moderate to severe atopic dermatitis in patients aged 6 months to 5 years, Regeneron announced in a press release.
The supplemental biologics application would allow Dupixent (dupilumab), a fully human monoclonal interleukin (IL)-4 and IL-13 inhibitor, to be used as an add-on maintenance treatment for children with moderate to severe atopic dermatitis whose disease is not controlled with topical medications.
If approved, it would be the first biologic medication available for this population.
Data from a phase 3 clinical trial evaluating the drug’s safety and efficacy in combination with topical corticosteroids (TCS) in children aged 6 months to 5 years supports the supplemental biologics application. The trial found patients treated with both Dupixent and TCS had significantly improved skin clearance and reduced itch compared with those treated with TCS alone.
The FDA has set a target action date of June 9.
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