FDA Approves New Dupixent Pre-filled Pen Designed to Support More Convenient Self-Administration image

The FDA has approved a 300mg single-dose pre-filled pen for Regeneron Pharmaceuticals, Inc. and Sanofi's 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. 

"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," says George D. Yancopoulos, MD, PhD, 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."

The 300mg pre-filled pen is expected to be available in the US 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 200mg pre-filled pen. The pre-filled syringe continues to be available in both 200mg and 300mg doses for use in a clinic or at home by self-administration. Both methods of administration require training by a healthcare professional.

"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," says 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."