Sanofi and Regeneron’s Dupixent (dupilumab) has been approved by the US Food and Drug Administration (FDA) as an add-on maintenance treatment for adolescents with chronic rhinosinusitis with nasal polyps (CRSwNP).
The regulator’s decision, which expands its previous approval of the drug in CRSwNP patients aged 18 years and older, specifically applies to those aged 12 to 17 years with inadequately controlled cases.
CRSwNP is a chronic disease of the upper airway that obstructs the sinuses and nasal passages, causing severe congestion, nasal discharge, facial pain or pressure, and reduced sense of smell and taste.
Despite systemic steroids and surgery, many patients still experience uncontrolled symptoms and the recurrence of nasal polyps, with approximately 9,000 adolescents in the US living with inadequately controlled CRSwNP.
Already approved for a range of indications, Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 pathways, shown in the Dupixent development programme to be central drivers of the type 2 inflammation that plays a major role in multiple related diseases, including CRSwNP.
Among the evidence contributing to the latest approval of the therapy was positive results from the late-stage SINUS-24 and SINUS-52 trials, in which Dupixent significantly improved nasal congestion/obstruction severity, nasal polyp size and sense of smell, and reduced the need for systemic corticosteroids or surgery in adults with inadequately controlled CRSwNP compared to placebo at 24 weeks.
The authorisation was also supported by pharmacokinetic data from adult and adolescent patients aged 12 years and older with moderate-to-severe asthma and adults with inadequately controlled CRSwNP, as well as safety data of Dupixent in adolescents aged 12 years and older with moderate-to-severe asthma.
Brian Foard, executive vice president, head, specialty care at Sanofi, said: “This latest approval for Dupixent marks the first time a biologic is specifically indicated for adolescents with CRSwNP, offering them an option beyond current standard of care.”
The approval comes just days after Dupixent was approved by the Medicines and Healthcare products Regulatory Agency as an add-on maintenance treatment for chronic obstructive pulmonary disease.