FDA Approves Pre-Filled Dupilumab Pen

The US Food and Drug Administration (FDA) has approved single-dose 300 mg pre-filled dupilumab (Dupixent) pen for all dupilumab indications for patients at least 12 years old.

The pre-filled pen, developed by Regeneron Pharmaceuticals and Sanofi, is now approved for use in certain patients with atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis (CRSwNP) for at-home administration.

The pen features a hidden needle and a single-press auto-injection, as well as visual and audio feedback to aid in administration.

Officials are expecting the treatment to be available in the US in the third quarter of 2020.

"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," George D. Yancopoulos, MD, PhD, Co-founder, President and Chief Scientific Officer at Regeneron, said in a statement. "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."

Investigators from the pharmaceutical companies are also working with the FDA on a 200 mg version of the 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.

"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," Bill Sibold, Executive Vice President and Head of Sanofi Genzyme, said in a statement. "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."