FDA Accepts Dupixent sBLA for Priority Review

The FDA has accepted a supplemental Biologics License Application (sBLA) for Priority Review for Dupixent (dupilumab; Sanofi, Regeneron). According to the sBLA, Dupixent can used as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP).  

CRSwNP is a chronic disease of the upper airway. The disease is driven by type 2 inflammation and it is characterized by polyps that obstruct the sinuses and nasal passages. Oftentimes patients with severe CRSwNP experience recurrence despite previous treatment with surgery or systemic corticosteroids. Currently, there are no FDA-approved biologic medicines for the treatment of CRSwNP. Dupixent is a targeted biologic therapy that inhibits signaling of interleukin-4 and interleukin-13—these are two proteins that are believed to play a central role in type 2 inflammation.  

Data from two Phase 3 trials that evaluated efficacy and safety of Dupixent when combined with standard-of-care corticosteroid nasal spray in patients with recurring severe CRSwNP support the sBLA.  

Currently, Dupixent is approved for the treatment of adults with atopic dermatitis (eczema) that is not well controlled with prescription therapies. Further, the treatment is approved for use with other asthma medicines for the maintenance treatment of moderate to severe asthma in individuals aged 12 years and older whose asthma is not controlled on their current asthma medicines.  

The FDA is expected to make a decision by June 26, 2019.  

—Julie Gould

Reference:

Sanofi. FDA to undertake priority review of Dupixent® (dupilumab) for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps [press release]. https://www.globenewswire.com/news-release/2019/03/08/1750371/0/en/Sanofi-FDA-to-undertake-priority-review-of-Dupixent-dupilumab-for-adults-with-inadequately-controlled-severe-chronic-rhinosinusitis-with-nasal-polyps.html. Accessed March 11, 2019.