Sanofi and Regeneron Pharmaceuticals’ Dupixent (dupilumab) has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) approving it as an add-on maintenance therapy for two specific types of asthma. This latest approval marks a pivotal advancement for patients with moderate-to-severe asthma.

New FDA Approval for Dupixent: Key Details

The FDA’s green light extends Dupixent’s indication to include patients aged 12 years and older with either eosinophilic phenotype asthma or oral corticosteroid-dependent asthma. This approval underscores Dupixent’s role in addressing the needs of those with particularly challenging forms of asthma.

Dupixent works by inhibiting the overactive signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13). These proteins are central to the Type 2 inflammation that exacerbates moderate-to-severe asthma. By targeting these proteins, Dupixent helps reduce levels of inflammatory biomarkers such as fractional exhaled nitric oxide (FeNO), immunoglobulin E (IgE), and eotaxin-3 (CCL26), which are associated with asthma severity.

Clinical Trial Successes and Benefits

The pivotal clinical trials for Dupixent involved 2,888 adult and adolescent patients across three randomized, placebo-controlled, multicenter trials. These trials demonstrated the drug’s efficacy in reducing severe asthma exacerbations and the need for oral corticosteroids while improving lung function and overall quality of life.

In the largest study, Trial 2, Dupixent showed a significant reduction in exacerbations and improved lung function, particularly in patients with eosinophil counts of 150 cells/microliter or higher, accounting for 70% of participants. Trial 3, which focused on severe, oral corticosteroid-dependent asthma, revealed that Dupixent reduced the average daily use of oral corticosteroids by 70% compared to 42% with placebo. Notably, over half of the patients on Dupixent were able to completely eliminate their use of oral corticosteroids.

Expert Insights and Future Directions

George D. Yancopoulos, President and Chief Scientific Officer of Regeneron Pharmaceuticals, emphasized the significance of this approval: “Dupixent is now approved in the U.S. for two important groups of uncontrolled asthma patients – those who are moderate-to-severe with an eosinophilic phenotype or those with oral corticosteroid-dependent asthma.” He highlighted that the clinical trials showed a reduction in severe exacerbations and improved quality of life, reinforcing the drug’s impact on lung function.

Sanofi’s CEO, Olivier Brandicourt, echoed these sentiments: “Today’s approval marks a significant development for certain people with moderate-to-severe asthma aged 12 years and older. For patients dependent on oral corticosteroids, Dupixent improved lung function, reduced oral corticosteroid use, and reduced exacerbations regardless of baseline eosinophil levels.” He further noted the ongoing need for effective treatments for asthma and the potential for Dupixent to provide relief where other biologics may not be effective.

The FDA approval of Dupixent for asthma represents a major advancement in the treatment landscape for moderate-to-severe asthma. With its proven efficacy in reducing exacerbations and corticosteroid use, Dupixent offers a promising new option for patients and continues to demonstrate its broader impact on Type 2 inflammatory diseases.

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