The Food and Drug Administration has approved a prefilled pen formulation of Dupixent (dupilumab; Sanofi and Regeneron), providing another option for administering the treatment.
The Dupixent prefilled pen delivers 300mg of dupilumab in 2mL of solution for subcutaneous injection. It is only indicated for use in adults and adolescents aged 12 years and older. To help with administration, the prefilled pen includes visual and audio cues, as well as a hidden needle and a single-press injection. Like the prefilled syringe, use of the prefilled pen requires training by a healthcare professional.
Commenting on the approval, George D. Yancopoulos, MD, PhD, Co-founder, President and Chief Scientific Officer at Regeneron, said: “The Dupixent prefilled pen was specifically designed to provide patients with an easy-to-use, convenient option so they can feel more comfortable administering their injections.”
The prefilled pen is expected to be available in the third quarter of 2020. The prefilled syringe, both in 200mg and 300mg doses, will continue to be available as well.
Dupixent, an interleukin-4 receptor alpha antagonist, is indicated for the treatment of patients aged 6 years 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 an add-on maintenance treatment in patients with moderate to severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma; and as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps.
For more information visit dupixent.com.