31 Jul FDA Approves Dupixent® (dupilumab) Pre-Filled Pen For All Indications in Patients Aged 12 Years and Older
MedicalResearch.com Interview with:
Elizabeth Laws, PhD
Vice President and Global Project Head for Dupilumab/Dupixent
Marcie Ruddy, MD, MA
Strategic Program Direction, Immunology and Inflammation
Dr. Laws and Dr. Ruddy discuss the FDA approval of a 300 mg single-dose pre-filled pen for Dupixent® (dupilumab) for all indications in patients aged 12 years and older.
MedicalResearch.com: What is the background for this announcement? What are the main indications for Dupixent?
Response: Until now, Dupixent 300 mg dose was available only in pre-filled syringe for administration. The approval of the pre-filled pen provides an additional, easy-to-use option for patients to self-administer Dupixent.
Dupixent is approved to treat patients aged 6 years and older with uncontrolled moderate-to-severe atopic dermatitis (AD) and can be used with or without topical treatments. Dupixent is also approved for use with other medicines for the maintenance treatment of uncontrolled moderate-to-severe eosinophilic or oral steroid dependent asthma in patients aged 12 years and older, and with other medicines for the maintenance treatment of uncontrolled chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults, respectively.
The pre-filled pen is approved for use in patients prescribed Dupixent who are 12 years of age and older across current indications, at the 300 mg dose.
MedicalResearch.com: How does Dupixent differ from other treatments for atopic diseases?
Response: Dupixent is a biologic therapy that works differently from existing therapies that treat atopic diseases. It addresses type 2 inflammation – an underlying cause of atopic dermatitis, asthma and CRSwNP.
As a fully-human monoclonal antibody, Dupixent inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, which are key drivers of type 2 inflammation that plays a major role in diseases like AD, asthma and CRSwNP. Targeting the signaling of these key cytokines within the type 2 inflammation pathway has demonstrated clinical benefit. Targeted treatments tend to be associated with fewer side effects than treatments with broad immunosuppressive activity due to their more selective immunomodulation. Dupixent is not an immunosuppressant.
MedicalResearch.com: What are the benefits of the new pre-filled pen?
Response: The Dupixent pre-filled pen was designed to provide patients with an easy-to-use, convenient option so they can feel more comfortable administering their injections at home. Developed based on patient input, the pre-filled pen is delivered by a self-injection with a single press. The injection window and audible ‘click’ provides visual and audible confirmation of complete dose delivery to patients. The latex-free device’s needle is hidden. Now, patients aged 12 years and older prescribed Dupixent at the 300 mg dose can choose the latex-free, single-dose, pre-filled syringe or pen. The pre-filled pen will be available to patients in the U.S. in the third quarter of 2020.
FDA approved a 300 mg single-dose pre-filled pen for Dupixent® (dupilumab) for all indications in patients aged 12 years and older.
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