FDA Grants Priority Review to Sanofi and Regeneron's Dupixent for Bullous Pemphigoid

Sanofi and Regeneron have received priority review status from the US Food and Drug Administration (FDA) for their drug Dupixent (dupilumab), which is intended to treat adults suffering from bullous pemphigoid (BP). BP is a chronic skin condition predominantly affecting older individuals, characterized by severe itching, blisters, and painful lesions. Despite existing treatments, approximately 27,000 adults in the United States experience BP that cannot be controlled with systemic corticosteroids.

Dupixent is a fully human monoclonal antibody already approved for various conditions. It works by inhibiting the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, which are key contributors to type 2 inflammation. This inflammation is a significant factor in several diseases, including BP. If the FDA approves it for this new application, Dupixent will become the first targeted treatment for BP available in the United States.

The supplemental biologics license application for Dupixent was supported by results from the phase 2/3 ADEPT clinical trial. This trial assessed the drug's safety and efficacy in 106 adults with moderate-to-severe BP. The study reached its primary endpoint, showing that patients treated with Dupixent were five times more likely to achieve sustained disease remission compared to those who received a placebo. Additionally, the drug significantly reduced disease severity, itch, and the need for oral corticosteroids when compared to the placebo group.

The FDA’s priority review designation is reserved for therapies that may offer significant improvements in the treatment, diagnosis, or prevention of serious medical conditions. This designation accelerates the regulatory review process, aiming for a decision within six months, in contrast to the ten-month timeline typical of standard reviews.

This announcement comes shortly after the FDA had approved Dupixent for another indication. Less than five months ago, the drug was approved as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. This made Dupixent the first biologic medicine approved in the US for this specific patient group.

Paul Hudson, the CEO of Sanofi, emphasized the transformative impact Dupixent has had on the treatment landscape for diseases driven by type 2 inflammation, highlighting the high unmet medical needs in this area. As of September, one million patients worldwide have been treated with Dupixent for various approved indications.

Overall, the FDA’s consideration of Dupixent for BP is a significant step forward in potentially offering a new therapeutic option for patients who have limited effective treatments. If approved, Dupixent could provide relief for many individuals suffering from this debilitating condition and further solidify its role as a critical treatment for diseases associated with type 2 inflammation.