FDA approves dupilumab for chronic sinusitis with nasal polyps

  • FDA

  • de Miriam Davis, PhD
  • Clinical Essentials
El acceso al contenido completo es sólo para profesionales sanitarios registrados. El acceso al contenido completo es sólo para profesionales sanitarios registrados.

Takeaway

  • The FDA has approved the IL-4 receptor α-inhibitor dupilumab (Dupixent) for inadequately controlled chronic rhinosinusitis with nasal polyps in adults.

Why this matters

  • This is the first treatment indicated for chronic rhinosinusitis with nasal polyps.
  • Nasal polyps can lead to loss of smell and frequently require polyp removal surgery.
  • Prescribing information is found here.

Key points

  • FDA-recommended dose: 300 mg given every other week by subcutaneous injection with prefilled syringe.
  • Efficacy was established in 2 phase 3 trials involving 724 adults who were symptomatic despite receiving intranasal corticosteroids. Four important outcomes were found:
    • Reductions in nasal polyp size vs placebo.
    • Reductions in nasal congestion vs placebo.
    • Patient-reported increased ability to smell.
    • Less nasal polyp surgery and oral steroids.
  • FDA warnings and precautions include serious allergic reactions and eosinophilic conditions such as vasculitic rash, worsening pulmonary symptoms, and/or neuropathy.
  • Most frequent adverse events include:
    • Injection site reactions.
    • Eye and eyelid inflammation.
  • Patients should be encouraged to contact their provider if they have new or worsening eye symptoms, such as redness, itching, pain, or visual changes.
  • Dupilumab was first approved by the FDA in 2017 for atopic dermatitis not adequately controlled by topical therapies, and in 2018 for moderate to severe eosinophilic asthma or oral corticosteroid-dependent asthma.