The US Food and Drug Administration (FDA) has expanded the approval of Dupixent (dupilumab) to include adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
This is the first treatment available in this age group for CRSwNP, a chronic inflammatory disease of the upper airway.
Approved for adults in June 2019, Dupixent’s new indication was granted priority review by the FDA.
The decision was supported by results from two pivotal trials in adults, SINUS-24 and SINUS-52, which demonstrated significant improvements in nasal congestion, polyp size and sense of smell over 24 weeks compared to placebo.
The FDA also considered pharmacokinetic data from both adult and adolescent patients with moderate-to-severe asthma and adults with inadequately controlled CRSwNP.
The safety profile of Dupixent in adolescents with moderate-to-severe asthma also contributed to the FDA’s decision.
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By GlobalDataRegeneron board co-chair, president and chief scientific officer George Yancopoulos said: 鈥淲e are pleased to bring the well-established efficacy and safety of Dupixent to the many children suffering from chronic rhinosinusitis with nasal polyps, which can make their breathing more laborious and difficult, and also deprive them of their sense of smell.
鈥淢ore than one million patients around the world are now being treated with Dupixent, from infants to adults, and across multiple diseases exacerbated by type 2 inflammation, from asthma to atopic dermatitis.鈥�
Developed using Regeneron’s VelocImmune technology, Dupixent is a fully human monoclonal antibody. It targets the interleukin-4 and interleukin-13 pathways but is not an immunosuppressant.
The broader impact of Dupixent is evident in its global reach, with regulatory approvals in more than 60 countries for atopic dermatitis, asthma, chronic obstructive pulmonary disease, chronic spontaneous urticaria, CRSwNP, eosinophilic esophagitis and prurigo nodularis.
