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FDA approves new Dupixent prefilled pen

23 Jun 2020

FDA approves a 300 mg single-dose pre-filled pen for Dupixent. (Image: courtesy of Regeneron Pharmaceuticals.)

The prefilled pen supports more convenient self-administration for patients with chronic type 2 inflammatory diseases.

Regeneron Pharmaceuticals and Sanofi have received FDA approval for a 300 mg single-dose prefilled pen for Dupixent (dupilumab).

The prefilled pen is approved for all Dupixent indications in patients aged 12 years and older, which includes use in certain patients with atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP), for at-home administration.

This new prefilled pen is expected to provide patients with a more convenient option for administering Dupixent.

The 300 mg pre-filled pen, which is expected to be available in the US in the third quarter of 2020, features a hidden needle and single-press auto-injection, along with visual and audio feedback to help with administration.

Regeneron and Sanofi are working with the FDA to provide additional data they require to complete their review of the 200 mg pre-filled pen. The pre-filled syringe continues to be available in both 200 mg and 300 mg doses for use in a clinic or at home by self-administration. Both methods of administration require training by a healthcare professional.

Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, and is not an immunosuppressant. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and CRSwNP.

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