Sanofi/Regneron's Dupixent Application For Asthma In Children Accepted For FDA Review

The FDA has accepted for review the supplemental marketing application seeking approval for Dupixent (dupilumab). It is an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma, jointly developed by Sanofi SA (NASDAQ: SNY) and Regeneron Pharmaceuticals Inc (NASDAQ: REGN) under a global collaboration agreement.

• The target action date is October 21.
• EU regulatory submission of Dupixent for children aged 6 to 11 years with asthma is up next.
• It is currently approved as an add-on treatment for patients with uncontrolled moderate-to-severe asthma aged 12 and older with elevated eosinophils or oral corticosteroid-dependent asthma.
• Dupixent is a fully human monoclonal antibody that inhibits the interleukin-4 (IL-4) signaling and interleukin-13 (IL-13) pathways that drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyposis, atopic dermatitis, and eosinophilic esophagitis.
• Price Action: REGN shares closed 1.8% lower at $446.73, and SNY shares closed 1% lower at $45.46 on Wednesday.