The U.S. Food and Drug Administration (FDA) has approved a 300 mg single-dose pre-filled pen for Dupixent® (dupilumab). The pre-filled 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 pre-filled pen will provide patients with a more convenient option for administering Dupixent.
"We know that administering or receiving an injection, especially for a medicine that patients need to receive regularly, can seem daunting for patients or their parents or caregivers," said Bill Sibold, Executive Vice President and Head of Sanofi Genzyme. "The Dupixent pre-filled pen was developed based on patient input and offers the latest technology, including visual and audio cues, to help provide support when taking this medicine."
The 300 mg pre-filled pen is expected to be available in the U.S. in the third quarter of 2020. The pre-filled pen 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.
"Chronic type 2 inflammatory diseases such as atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyps can be incredibly complex to manage, leaving patients burdened and apprehensive about their treatment options," said George D. Yancopoulos, M.D., Ph.D., Co-founder, President and Chief Scientific Officer at Regeneron. "The Dupixent pre-filled pen was specifically designed to provide patients with an easy-to-use, convenient option so they can feel more comfortable administering their injections."
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Regeneron and Sanofi are committed to helping patients in the U.S. who are prescribed Dupixent gain access to the medicine and receive the support they may need with the DUPIXENT MyWay® program. For more information, please call 1-844-DUPIXENT (1-844-387-4936) or visit www.DUPIXENT.com.
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. Across all approved indications globally, more than 150,000 patients have been treated with Dupixent.
Dupixent is approved in the U.S. to treat patients aged 6 years and older with moderate-to-severe atopic dermatitis that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies; for use with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in patients aged 12 years and older whose asthma is not controlled with their current asthma medicines; and for use with other medicines for the maintenance treatment of CRSwNP in adults whose disease is not controlled. In adolescents 12 years of age or older, it is recommended that Dupixent be administered by or under the supervision of an adult. In children younger than 12 years of age, Dupixent should be administered by a caregiver.
Outside of the U.S., Dupixent is approved for specific patients with moderate-to-severe atopic dermatitis and certain patients with asthma in a number of other countries around the world, including the EU and Japan. Dupixent is also approved in the EU and Japan to treat certain adults with severe CRSwNP. The 200 mg and 300 mg pre-filled pens are currently approved in the EU.