Sanofi and Regeneron’s Dupixent (dupilumab) has been accepted for priority review by the US Food and Drug Administration (FDA) to treat adults with bullous pemphigoid (BP).
BP is a chronic and relapsing skin disease that mainly affects older adults. The condition is characterised by intense itch, blisters and painful lesions and, despite current treatment options, approximately 27,000 adults in the US are living with BP that is uncontrolled by systemic corticosteroids.
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 BP.
If authorised for this latest indication, Dupixent would be the first and only targeted medicine to treat BP in the US.
The companies’ supplemental biologics licence application for the drug was supported by the phase 2/3 ADEPT trial evaluating the efficacy and safety of Dupixent in 106 adults with moderate-to-severe BP.
The study met its primary endpoint, with five times more Dupixent-treated patients achieving sustained disease remission compared to those receiving placebo. Dupixent was also shown to significantly reduce disease severity, itch and oral corticosteroids use compared to placebo.
The FDA grants priority review to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.
A priority review designation means the regulator will aim to take action on the application within six months, compared to ten months under its standard review pathway.
The latest decision on Dupixent comes less than five months after the FDA approved the drug as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease and an eosinophilic phenotype, making it the first biologic medicine approved in the US for this patient population.
Sanofi’s chief executive officer, Paul Hudson, said at the time of the September announcement: “Dupixent has already shown it can revolutionise the treatment paradigm of many diseases driven in part by type 2 inflammation with high unmet medical needs, with one million patients being treated globally across all currently approved indications.”