FDA Approval Allows for Use of Dupixent Prefilled Pens in Younger Patients

The Food and Drug Administration (FDA) has expanded the approval of the Dupixent^® (dupilumab) single-dose prefilled pen to include use in pediatric patients 2 years of age and older for approved indications. Previously, the prefilled pen was only indicated for use in patients 12 years of age and older.

Dupixent is available as 200mg/1.14mL and 300mg/2mL solutions in single-dose prefilled pens, featuring a hidden needle and single-press auto-injection, along with visual and audio feedback to help with administration. In children 2 years to less than 12 years of age, Dupixent should be given by a caregiver.

Dupixent is indicated for the following:

Treatment of patients 6 months of age and older with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
As add-on maintenance treatment of patients 6 years of age and older with moderate to severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma.
As add-on maintenance treatment in patients 18 years of age and older with inadequately controlled chronic rhinosinusitis with nasal polyposis.
Treatment of patients 12 years of age and older, weighing at least 40kg, with eosinophilic esophagitis.
Treatment of patients 18 years of age and older with prurigo nodularis.

The product is also available as a single-dose prefilled syringe for adult and pediatric patients aged 6 months and older in the following strengths: 300mg/2mL, 200mg/1.14mL, and 100mg/0.67mL.

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