Regeneron Pharmaceuticals and Sanofi have been granted approval by the US Food and Drug Administration (FDA) for Dupixent (dupilumab) as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
This decision expands on the FDA’s initial approval from June 2019, which covered CRSwNP in patients aged 18 years and older. The FDA evaluated Dupixent for this expanded indication under a priority review, a process used for medicines that may offer significant improvements in effectiveness or safety in the treatment of serious conditions.
Regeneron Pharmaceuticals president and chief scientific officer and board co-chair George Yancopoulos said: “We 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.
“More 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.”
The approval of Dupixent for this new indication is based on data from two Phase 3 clinical trials, SINUS-24 and SINUS-52, conducted with adults who had inadequately controlled CRSwNP.
The trials showed that Dupixent led to improvements in nasal congestion, nasal polyp size, and sense of smell, and reduced the need for systemic corticosteroids or surgery at 24 weeks when compared to a placebo.
The approval is also supported by pharmacokinetic data from adult and adolescent patients aged 12 years and older with moderate-to-severe asthma, as well as safety data of Dupixent in adolescents within the same age range.
The safety profile of Dupixent in the SINUS-24 and SINUS-52 trials in adults was generally consistent with the known safety profile of Dupixent in its other approved uses.
Adverse events observed more frequently with Dupixent (at least 1%) compared to placebo in the 24-week safety analysis included injection site reactions, eosinophilia, insomnia, toothache, joint pain, gastritis, and conjunctivitis.
Sanofi executive vice president and speciality care head Brian Foard said: “This latest approval for Dupixent marks the first time a biologic is specifically indicated for adolescents with chronic rhinosinusitis with nasal polyps, offering them an option beyond current standard of care.”
Dupixent was developed using Regeneron’s VelocImmune technology. It is a fully human monoclonal antibody that inhibits signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways.
It has received regulatory approvals in over 60 countries for various indications, including atopic dermatitis, asthma, CRSwNP, eosinophilic oesophagitis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease (COPD) in different age groups.
In July 2024, the European Commission also approved Dupixent for treating adults with uncontrolled COPD.
