This approval expands the initial 2019 FDA approval in CRSwNP for patients aged 18 years and older.
RT’s Three Key Takeaways:
- Expanded FDA Approval for Adolescents: The FDA has approved Dupixent as an add-on maintenance treatment for adolescents aged 12-17 with chronic rhinosinusitis with nasal polyps (CRSwNP), expanding its original approval for adults in 2019.
- New Treatment Option for CRSwNP: Dupixent offers a new biologic treatment option for adolescents with inadequately controlled CRSwNP, a condition often managed by systemic steroids and surgery, but where many patients continue to experience symptoms and polyp recurrence.
- Support from Clinical Trials: The approval is based on data from the SINUS-24 and SINUS-52 trials, which demonstrated significant improvements in nasal congestion, polyp size, and sense of smell, along with reductions in the need for corticosteroids or surgery.
Regeneron Pharmaceuticals Inc and Sanofi announced that the US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adolescent patients aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
This approval expands the initial 2019 FDA approval in CRSwNP for patients aged 18 years and older. The FDA evaluated Dupixent for this expanded indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.
CRSwNP is a chronic disease of the upper airway, driven in part by type 2 inflammation, that obstructs the sinuses and nasal passages. It can lead to breathing difficulties, nasal congestion and discharge, reduced or loss of sense of smell and taste, facial pressure, sleep disturbance, and overall reduction in quality of life.
Though systemic steroids and surgery are the standard treatment for CRSwNP in this age group and can provide relief, many patients may still experience uncontrolled symptoms and the recurrence of nasal polyps. In the US, approximately 9,000 adolescents live with inadequately controlled CRSwNP.
“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,” says George D. Yancopoulos, MD, PhD, board co-chair, president and chief scientific officer at Regeneron, and a principal inventor of Dupixent, in a release.
Dupixent Improves Symptoms in Clinical Trials
The approval is supported by evidence from two positive pivotal trials in adults with inadequately controlled CRSwNP. In the SINUS-24 and SINUS-52 trials, Dupixent significantly improved nasal congestion/obstruction severity, nasal polyp size, and sense of smell, while also reducing the need for systemic corticosteroids or surgery at 24 weeks compared to placebo.
The approval is also supported by pharmacokinetic data from adult and adolescent patients aged 12 years and older with moderate-to-severe asthma and adult patients with inadequately controlled CRSwNP, along with the safety data of Dupixent in adolescents aged 12 years and older with moderate-to-severe asthma.
In the SINUS-24 and SINUS-52 trials, the safety of Dupixent in adults was generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent (≥1%) compared to placebo in SINUS-24 and SINUS-52 (24-week safety pool) were injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia and conjunctivitis.
“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,” says Brian Foard, executive vice president, head of specialty care at Sanofi, in a release. “Dupixent is a cornerstone of our leadership in immunology, and this latest approval supports our continued commitment to chasing the miracles of science for patients with unmet medical needs.”
