The Food and Drug Administration (FDA) has approved Dupixent (dupilumab; Regeneron and Sanofi) as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.
Dupilumab, an interleukin-4 receptor alpha antagonist, is a human monoclonal antibody of the IgG4 subclass that binds to the IL-4Rα subunit and blocks IL-4 and IL-13 signaling, thereby inhibiting IL-4 and IL-13 cytokine-induced inflammatory responses, including the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE. The approval was based on data from 3 double-blind, placebo-controlled trials involving 2888 patients.
In Trial 2 (N=1902), the largest study evaluating the frequency of severe asthma exacerbations, dupilumab reduced exacerbations and improved lung function in the overall population compared with placebo. Moreover, greater reductions in severe exacerbations were observed in patients with higher baseline blood eosinophil levels (≥150 cells/µL). In patients with baseline blood eosinophils of ≥300 cells/µL, treatment with dupilumab reduced severe exacerbations by 67% compared with placebo.
In Trial 3 (N=210), which evaluated oral corticosteroid reduction, the mean percent reduction in oral corticosteroid dose from baseline was 70% in patients receiving dupilumab vs 42% with placebo; 52% (N=54) of patients receiving dupilumab had a 100% reduction in their oral corticosteroid dose. In dupilumab-treated patients, effects on lung function and on oral corticosteroid and exacerbation reduction were similar irrespective of baseline blood eosinophil levels.
In the asthma clinical trials, the most common adverse reactions were injection site reactions, oropharyngeal pain, and eosinophilia.
In addition to the 300mg dosage strength, Dupixent is now available in a 200mg strength for the treatment of patients with asthma; both strengths are supplied in single-dose pre-filled syringes.
Dupixent is also approved for the treatment of moderate-to-severe atopic dermatitis in adults who are not adequately controlled with topical prescription therapies or when they are not advisable.
“Following the approvals in atopic dermatitis and asthma, and recently announced positive Phase 3 results in chronic rhinosinusitis with nasal polyps, we are committed to advancing our broad development program in additional Type 2 inflammatory diseases,” said George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer of Regeneron.
For more information visit Dupixent.com.