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

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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.
 

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Posted-In: asthmaBiotech News Health Care FDA General

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