The US Food and Drug Administration (FDA) has accepted Sanofi’s Dupixent (dupilumab) for Priority Review.
The supplemental Biologics License Application (sBLA) accepted is for the drug as treatment for inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP).
Patents with the disorder often experience recurrence despite previous treatment with surgery or systemic corticosteroids, hence the need for an alternative.
The FDA decision is supported by data from two pivotal Phase III trials evaluating the efficacy and safety of Dupixent when combined with standard-of-care corticosteroid nasal spray.
Both trials found 57% and 51% improvement in nasal congestion and obstruction severity, compared to a 19% and 15% improvement with placebo, significantly reducing chronic sinus disease in both trials.
Currently, there are no FDA-approved biologic medicines to treat this strain of sinusitis, which is a chronic disease of the upper airway predominantly driven by type II inflammation and characterised by polyps that obstruct the sinuses and nasal passages.
In the US, Dupixent is already approved for the treatment of adults with moderate-to-severe atopic dermatitis that is not well controlled with prescription therapies used on the skin, and for use with other asthma medicines for the maintenance treatment of moderate-to-severe asthma in people aged 12 years and older.
Persistent symptoms of CRSwNP have a substantial adverse impact on patients' health-related quality of life, which can be measured by a composite endpoint that includes reduced productivity and activities of daily living, inability to enjoy food, lack of sleep and fatigue.