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FDA approves dupilumab, injectible biologic, for eosinophilic asthma
The US Food and Drug Administration (FDA) approved dupilumab (Dupixent, Sanofi/Regeneron) as "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," according to the manufacturer's news release.
In randomized trials, asthmatic patients with higher blood eosinophil counts (≥ 150 cells/µL) failing corticosteroid treatment had reduced exacerbations while taking dupilumab. The improvements were highest for those with the highest eosinophil counts (≥ 300 cells/µL). Lung function also improved by ~30%.
In another trial, half of patients taking dupilumab were able to discontinue oral corticosteroids entirely.
Dupilumab blocks interleukin-4 (IL-4) and interleukin-13 (IL-13) action; these cytokines stimulate type 2 inflammation that contributes to asthma. Downstream effects of IL-3 and IL-4 inhibition include reduction in fractional exhaled nitric oxide and IgE levels.
Dupilumab is an injectible biologic given every other week. Patients can self-administer the injection.
Injection-site reactions, sore throat, and increased eosinophil levels occurred more often in patients taking dupilumab.
Although the indication for asthma treatment is news, dupilumab was already on the U.S. market with an indication for atopic dermatitis obtained in 2017.
In 2017, the wholesale cost of dupilumab for atopic dermatitis was estimated at $37,000 per year. The actual cost of dupilumab was expected to be lower as wholesale pricing does not include negotiated discounts, rebates, or patient assistance programs.
Source: FDA, Sanofi