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Dupilumab pre-filled pen approved by FDA


The U.S. Food and Drug Administration has approved a single-dose 300 mg pre-filled pen version of dupilumab (Dupixent, Sanofi and Regeneron) for the treatment of atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP) in U.S. patients 12 years and older.

A more convenient method for patients to self-administer dupilumab (Dupixent, Sanofi and Regeneron) is on the way with the recent U.S. Food and Drug Administration (FDA) approval of a 300 mg single-dose pre-filled pen for patients 12 years and older.

The pre-filled pen is approved for at-home administration to treat all of the biologic’s approved indications, including atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP) in the United States. Currently, 200 mg and 300 mg pre-filled pens of dupilumab are approved in the European Union (EU).1

MORE: Dupilumab approved by FDA for children with atopic dermatitis

"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, 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."

The pen works by a hidden needle and single-press auto injection that includes audio and visual feedback to help with self-administration; however, training for administration is required by a healthcare professional prior to self-use.

“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."

RELATED: Dupilumab safe for adolescents with atopic dermatitis

Dupilumab, a fully-human, monoclonal antibody, works to inhibit the signaling of interleukin-4 (IL-4) and IL-13, both of which have been found to be key drivers of the type 2 inflammation that plays a role in inflammatory conditions like atopic dermatitis.

Most recently, Dupilumab was approved for pediatric use in May 2020 to treat atopic dermatitis is children 6 to 11 years whose disease is not well controlled on topical prescription medication, making it the only FDA-approve biologic for patient 6-11 years.2

The 300 mg pre-filled pen is estimated to be available during the third quarter of 2020, according to a press release. Meanwhile, the FDA, along with Sanofi and Regeneron are working to complete the application review for the 200 mg version of the pre-filled pen.1


1. FDA approves new Dupixent (dupilumab) pre-filled pen designed to support more convenient self-administration. (2020, June 19). Retrieved June 29, 2020, from https://www.firstwordpharma.com/node/1734196?al=3a2380-a882871cf1564cc5f229595ac3bb61d7%5E%7C%5EMTEwOTg2Mg

2. Petronelli, M. (2020, May 26). Dupilumab approved by FDA for children with atopic dermatitis. Retrieved June 29, 2020, from https://www.dermatologytimes.com/view/dupilumab-approved-fda-children-atopic-dermatitis

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