Regeneron and Sanofi could soon be adding another indication to its blockbuster immunology drug Dupixent (dupilumab) after the US Food and Drug Administration (FDA) accepted an approval application for chronic sinus disease and designated it for priority review.
The supplemental biologics licence application (sBLA) is for Dupixent’s use as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). The drug is already approved for adults with this condition.
The agency has placed the application on priority review, an accelerated pathway granted for therapies that are significant improvements over current treatment options.
The FDA has set a target date of 15 September 2024, four months ahead of the normal review schedule as per priority review benefits. If approved, it would become the first treatment approved in the US for adolescents with CRSwNP.
CRSwNP is a chronic inflammatory disease that can lead to breathing difficulties, nasal congestion, and smell and taste impairment. Many patients also have other type 2 inflammatory diseases such as asthma.
Dupixent was first approved in 2017 for the treatment of atopic dermatitis, also known as eczema. Since then, the drug, given as an injection, has been approved in asthma, eosinophilic esophagitis, and adult CRSwNP patients.
The FDA will base its decision on whether to expand coverage to adolescent CRSwNP patients with efficacy data from two pivotal trials (SINUS-24 and SINUS-52). The trials were conducted in adults, but the sBLA also has safety data on Dupixent’s use in other conditions where it is approved for an adolescent population.
Dupixent is a monoclonal antibody that works by inhibiting the signalling of interleukin-4 and interleukin-13 pathways. Cytokines such as these play key roles in inflammation.
Regeneron and Sanofi, who began working together on antibodies 16 years ago, are also studying Dupixent in Phase III trials for chronic spontaneous urticaria and chronic pruritus of unknown origin.
Another potential approval could be on the horizon for the drug, with the FDA set to decide on its use in patients with chronic obstructive pulmonary disease (COPD) with type 2 inflammation by the end of next month. Similar to CRSwNP, the COPD application was accepted under priority review.
Dupixent saw sales of $11.59bn in 2023 – up 33% from the year before. GlobalData’s Pharma Intelligence Centre expects revenue to keep growing for the drug, with an estimated $22.7bn in annual sales by 2030.
GlobalData is the parent company of Pharmaceutical Technology.
