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FDA approves first treatment Dupixent (Dupilumab) for chronic rhinosinusitis with nasal polyps
The U.S. Food and Drug Administration today approved Dupixent (dupilumab) to treat adults with nasal polyps (growths on the inner lining of the sinuses) accompanied by chronic rhinosinusitis (prolonged inflammation of the sinuses and nasal cavity). This is the first treatment approved for inadequately controlled chronic rhinosinusis with nasal polyps.
“Nasal polyps can lead to loss of smell and often patients require surgery to remove the polyps,” said Sally Seymour, M.D., Director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “Dupixent provides an important treatment option for patients whose nasal polyps are not …
- June 26, 2019
The U.S. Food and Drug Administration today approved Dupixent (dupilumab) to treat adults with nasal polyps (growths on the inner lining of the sinuses) accompanied by chronic rhinosinusitis (prolonged inflammation of the sinuses and nasal cavity). This is the first treatment approved for inadequately controlled chronic rhinosinusis with nasal polyps.
“Nasal polyps can lead to loss of smell and often patients require surgery to remove the polyps,” said Sally Seymour, M.D., Director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “Dupixent provides an important treatment option for patients whose nasal polyps are not adequately controlled with intranasal steroids. It also reduces the need for nasal polyp surgery and oral steroids.”
Dupixent is given by injection. The efficacy and safety of Dupixent were established in two studies with 724 patients, 18 years and older with chronic rhinosinusitis with nasal polyps who were symptomatic despite taking intranasal corticosteroids. Patients who received Dupixent had statistically significant reductions in their nasal polyp size and nasal congestion compared to the placebo group. Patients taking Dupixent also reported an increased ability to smell and required less nasal polyp surgery and oral steroids.
Dupixent may cause serious allergic reactions and eye problems, such as inflammation of the eye (conjunctivitis) and inflammation of the cornea (keratitis). If patients experience new or worsening eye symptoms, such as redness, itching, pain or visual changes, they should consult their health care professional. The most common side effects reported include injection site reactions as well as eye and eyelid inflammation, which included redness, swelling and itching. Patients receiving Dupixent should avoid receiving live vaccines.
Dupixent was originally approved in 2017 for patients 12 and older with eczema that is not controlled adequately by topical therapies or when those therapies are not advisable. In 2018, Dupixent was approved as an add-on maintenance treatment for patients 12 years and older with moderate-to-severe eosinophilic asthma or with oral corticosteroid-dependent asthma.
The FDA granted this application Priority Review. The approval of Dupixent was granted to Regeneron Pharmaceuticals.
///////////Dupixent, dupilumab, fda 2019, nasal polyps, chronic rhinosinusitis, Priority Review, Regeneron Pharmaceuticals,
FDA approves new eczema drug Dupixent (dupilumab)
The U.S. Food and Drug Administration today approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent can be used with or without topical corticosteroids.
“FDA’s approval of Dupixent demonstrates our commitment to approving new and innovative therapies for patients with skin disease,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Eczema can cause significant skin irritation and discomfort for patients, so it is important to have a variety of treatment options available to patients, including those patients whose disease is not controlled by topical therapies.”
Atopic dermatitis, a chronic inflammatory skin disease, is often referred to as “eczema,” which is a general term for several types of inflammation of the skin. Atopic dermatitis is the most common of the many types of eczema; onset typically begins in childhood and can last through adulthood. The cause of atopic dermatitis is a combination of genetic, immune and environmental factors. In atopic dermatitis, the skin develops red, scaly and crusted bumps, which are extremely itchy. Scratching leads to swelling, cracking, “weeping” clear fluid, and finally, coarsening and thickening of the skin.
Dupixent is administered as an injection under the skin. Dupixent’s active ingredient is an antibody (dupilumab) that binds to a protein [interleukin-4 (IL-4) receptor alpha subunit (IL-4Ra)], that causes inflammation. By binding to this protein, Dupixent is able to inhibit the inflammatory response that plays a role in the development of atopic dermatitis.
The safety and efficacy of Dupixent were established in three placebo-controlled clinical trials with a total of 2,119 adult participants with moderate-to-severe atopic dermatitis not adequately controlled by topical medication(s). Overall, participants who received Dupixent achieved greater response, defined as clear or almost clear skin, and experienced a reduction in itch after 16 weeks of treatment.
Dupixent can cause side effects such as serious allergic reactions and eye problems, such as pink eye (conjunctivitis) and inflammation of the cornea (keratitis). If patients experience new or worsening eye symptoms such as redness, itching, pain or visual changes, they should consult a health care provider. The most common side effects include injection site reactions; cold sores in the mouth or on the lips; and eye and eyelid inflammation, including redness, swelling and itching.
The safety and efficacy of Dupixent have not been established in the treatment of asthma. Patients who also have asthma should not adjust or stop their asthma treatment without talking to their physicians.
The FDA granted the application for Dupixent Priority Review and Breakthrough Therapy designation.
The FDA granted the approval of Dupixent to Regeneron Pharmaceuticals, Inc.
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