New OTC Nasal Spray for Allergy Relief Granted FDA Approval
June 18, 2021 02:32pm
The drug is indicated for certain patients 12 years of age and older who have atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis for at-home administration.
Officials with the FDA have approved a 300 mg single-dose pre-filled pen for dupilumab (Dupixent, Regeneron) for certain patients 12 years of age and older who have atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis for at-home administration.
"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 Regeneron president and CEO George D. Yancopoulos, MD, PhD, in a press release. "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 dupilumab pen features a hidden needle and single-press auto-injection, along with visual and audio feedback to help with administration. 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, whereas the 300 mg dupilumab pen is expected to be available in the United States by Q3 2020.
Dupilumab has been studied in more than 10,000 patients across 50 clinical trials in various chronic diseases driven by type 2 inflammation. Further, dupilumab is being studied in a broad range of clinical development programs for diseases driven by allergic and other type 2 inflammation, including pediatric asthma, pediatric atopic dermatitis, eosinophilic esophagitis, and chronic obstructive pulmonary disease.
Serious adverse effects (AEs) may occur from dupilumab, including hypersensitivity, anaphylaxis, eye problems, and inflammation of the blood vessels. The most common AEs include injection site reactions, redness, swelling, cold sores of the mouth, itching, and insomnia.
FDA approves new Dupixent® (dupilumab) pre-filled pen designed to support more convenient self-administration. PR Newswire. https://www.prnewswire.com/news-releases/fda-approves-new-dupixent-dupilumab-pre-filled-pen-designed-to-support-more-convenient-self-administration-301080450.html. Published June 19, 2020. Accessed June 22, 2020.