Sanofi has obtained the US Food and Drug Administration (FDA) approval for Dupixent (dupilumab) as an add-on maintenance treatment for people suffering from moderate-to-severe asthma.
The approval is for patients aged 12 years and above with eosinophilic phenotype or oral corticosteroid-dependent asthma.
Dupixent is designed to inhibit overactive interleukin-4 (IL-4) and interleukin-13 (IL-13) signalling. IL-4 and IL-13 are known to be associated with type 2 inflammation that may underlie moderate-to-severe asthma.
Sanofi, in alliance with Regeneron, is investigating the drug in multiple clinical development programmes for conditions driven by type 2 inflammation, including inadequately controlled chronic rhinosinusitis with nasal polyps.
During the approval process, the FDA reviewed findings from a total of 2,888 adult and adolescent patients across three randomised, placebo-controlled, multi-centre clinical trials.
In largest of the three trials, patients receiving Dupixent were found to have experienced improved lung function and fewer exacerbations.
Data from the trial assessing severe, oral corticosteroid-dependent patients showed 70% decrease in average daily oral corticosteroid use with the investigational drug, compared to 42% in placebo group.
Sanofi CEO Olivier Brandicourt said: “For patients dependent on oral corticosteroids, Dupixent improved lung function, reduced oral corticosteroid use and reduced exacerbations regardless of baseline eosinophil levels.
“Despite the spectrum of treatments for asthma, there continues to be an unmet need for so many patients with moderate-to-severe asthma, and given that Dupixent works differently than other biologics, there is now a new treatment option for some of these patients.”
In a separate development, the pharmaceutical giant has received positive Committee for Medicinal Products for Human Use (CHMP) opinion for its dengue vaccine, Dengvaxia.
This recommendation will be considered by European Medicines Agency (EMA) for marketing authorisation of the vaccine.