Dupixent Approved for Moderate-To-Severe Asthma
The U.S. Food and Drug Administration (FDA) has announced approval of Dupixent® (dupilumab) as an add-on maintenance therapy in patients aged 12 years and older with moderate-to-severe asthma. It is the only biologic approved for two groups of people with uncontrolled asthma. It is a treatment that addresses the needs of those with the eosinophilic phenotype and with oral corticosteroid-dependent asthma. Eosinophils are inflammatory cells that can contribute to the development of asthma
Dupixent has been on the market since its original approval for atopic dermatitis in 2017. It is a monoclonal antibody designed for the treatment of allergic diseases including asthma and eczema. An anti-inflammatory, it is an anti-interleukin-4/-13 drug. Dupilumab is a biologic agent that is administered by subcutaneous (under the skin) injection. It comes as a single-dose pre-filled syringe with a needle shield. An add-on therapy for both indications, dupilumab can be given alone and in combination with other medications, including topical corticosteroids.1
Regeneron Pharmaceuticals, Inc. and Sanofi Genzyme made the approval announcement. Dupixent is marketed by the specialty care global business unit of Sanofi.
People with moderate-to-severe asthma often have uncontrolled, ongoing symptoms despite receiving appropriate standard-of-care therapy.12 This makes them good candidates for treatment with a biologic therapy. Asthmatics suffer from bouts of coughing, wheezing and difficulty breathing. They are at risk of severe asthma attacks that could end up in emergency room visits or hospitalizations. Oral corticosteroids may offer relief for severe, short-term symptoms. However, their ongoing, chronic use is limited to the most severe cases due to the potential for serious side effects. Dupixent is not indicated for the relief of acute bronchospasm or status asthmaticus.
How does Dupixent work?
There are many available treatments for asthma, but there has been an unmet need for patients with a moderate-to-severe form of the disease. With the approval of Dupixent, there is now another treatment option to benefit some of those people. Dupixent works differently than other biologics. It inhibits the overactive signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that contribute to the Type 2 inflammation that may cause moderate-to-severe asthma. This effect demonstrates a reduction of inflammatory biomarkers including fractional exhaled nitric oxide (FeNO), immunoglobulin E (IgE) and eotaxin-3 (CCL26).1, 2
Dupixent was found to reduce severe exacerbations (flare-ups) and oral corticosteroid use. It improved patient quality of life and users enjoyed significant and clinically meaningful improvements in lung function, regardless of baseline eosinophil levels.1
Dupixent injections should be initially administered under the guidance of a healthcare provider. They can be given in a clinic or, for convenience, at home by self-administration after training. For people with asthma, Dupixent comes in two doses (200 mg and 300 mg) given every other week at different injection sites after an initial loading dose of 600 mg.1,2
People taking Dupixent are eligible to participate in the MyWay program. This educational program offers support by trained nurse educators and offers access to tools and resources including injection training, prescription refills, and 24-hour nursing support.2
Side effects and warnings
The most common side effects include injection site reactions, sore throat pain, and cold sores in the mouth or on the lips. Eye and eyelid inflammation, including redness, swelling, and itching have occurred.1,2
As with any medication, always speak with your healthcare provider before stopping or changing your prescribed dose. Make sure to tell your physician about all other medications and supplements you are taking when considering Dupixent. This is important to avoid adverse drug interactions. You should not use Dupixent if you are allergic to dupilumab or any of the ingredients in Dupixent. Additional background can be found in the prescribing information.
Dupixent is currently under regulatory review for moderate-to-severe asthma in several other geographic areas, including Japan and in the European Union (EU). Sanofi and Regeneron also have a clinical development program that is examining dupilumab for other Type 2 inflammatory diseases including pediatric asthma and atopic dermatitis, numerous known allergies like grass and peanuts, and several other inflammatory conditions.1
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