FDA Approves Dupixent for Adolescents with CRSwNP

Sanofi and Regeneron's Dupixent (dupilumab) has received approval from the US Food and Drug Administration (FDA) as an additional maintenance treatment for adolescents suffering from chronic rhinosinusitis with nasal polyps (CRSwNP). This decision extends the drug's prior approval, which covered CRSwNP patients aged 18 years and older, to include those aged 12 to 17 years who have inadequately controlled cases.

CRSwNP is a chronic condition affecting the upper airway, leading to blocked sinuses and nasal passages. This obstruction results in severe congestion, nasal discharge, facial pain or pressure, and diminished senses of smell and taste. Despite treatments with systemic steroids and surgical interventions, many patients continue to struggle with uncontrolled symptoms and recurring nasal polyps. In the United States, approximately 9,000 adolescents are living with inadequately controlled CRSwNP.

Dupixent is a fully human monoclonal antibody that inhibits the signaling of interleukin-4 and interleukin-13 pathways. These pathways are central drivers of type 2 inflammation, which plays a key role in multiple related diseases, including CRSwNP. The drug has already been approved for a variety of other conditions.

The latest FDA approval was supported by evidence from the SINUS-24 and SINUS-52 trials. These late-stage studies demonstrated that Dupixent significantly improved several symptoms in adults with inadequately controlled CRSwNP. Specifically, the drug reduced the severity of nasal congestion/obstruction, decreased the size of nasal polyps, and enhanced the sense of smell. Additionally, it lessened the need for systemic corticosteroids or surgical procedures compared to a placebo at 24 weeks.

The approval also took into account pharmacokinetic data from both adult and adolescent patients aged 12 years and older who have moderate-to-severe asthma, as well as adults with inadequately controlled CRSwNP. Safety data for Dupixent in adolescents with moderate-to-severe asthma also contributed to this decision.

Brian Foard, the executive vice president and head of specialty care at Sanofi, commented on the approval. He noted that this marks the first time a biologic is specifically indicated for adolescents with CRSwNP, providing an option beyond the current standard of care.

This FDA approval follows closely on the heels of another significant endorsement for Dupixent. The Medicines and Healthcare products Regulatory Agency recently approved the drug as an add-on maintenance treatment for chronic obstructive pulmonary disease.

By expanding the use of Dupixent to younger patients, Sanofi and Regeneron aim to address a pressing need in the treatment of chronic rhinosinusitis with nasal polyps. The drug offers hope to adolescents who have not found relief through existing treatments, potentially improving their quality of life and reducing the burden of this chronic condition.