Biologic gets asthma indication

A novel treatment for patients with moderate-to-severe asthma is now on the market.

FDA recently approved a new indication for dupilumab (Dupixent, Regeneron Pharmaceuticals and Sanofi) as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Dupixent is already approved to treat moderate-to-severe atopic dermatitis.

Dupixent’s wholesale acquisition cost is $38,100. However, actual costs to patients, payers and health systems are anticipated to be lower as this pricing does not reflect discounts, rebates or patient assistance programs, Michael Jones, vice president of Regeneron’s Immunology Commercial Business Unit, told FormularyWatch.

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“Despite available treatments, there are significant unmet needs for patients with moderate-to-severe asthma. Dupixent is the only biologic approved for both moderate and severe asthma patients with eosinophilic phenotype and the only biologic approved for oral corticosteroid-dependent asthma, regardless of phenotype,” Neil Graham, vice president of Immunology & Inflammation at Regeneron, told FormularyWatch.

In addition, Dupixent is also the only asthma biologic that offers patient self-administration at home and is the only asthma biologic also approved for adult patients with moderate-to-severe atopic dermatitis, a type 2 inflammatory disease driven by the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathway, Graham said.

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Dupixent inhibits the overactive signaling of IL-4 and IL-13, 2 key proteins that contribute to the type 2 inflammation that may underlie moderate-to-severe asthma. This effect is associated with the reduction of inflammatory biomarkers including fractional exhaled nitric oxide (FeNO), immunoglobulin E (IgE) and eotaxin-3 (CCL26).

In clinical trials, Dupixent reduced severe exacerbations, improved lung function, reduced oral corticosteroid use and improved health-related quality of life, according to Graham.

For people with asthma, Dupixent comes in 2 dosage strengths (200 mg and 300 mg) for subcutaneous injection every other week at different injection sites after an initial loading dose.  For patients with oral corticosteroid-dependent asthma, or patients with atopic dermatitis for whom Dupixent is indicated, Dupixent comes in one dosage strength (300 mg) for subcutaneous injection every other week at different injection sites after an initial loading dose.

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