Dupixent FDA approval : Dupixent (dupilumab), an eczema drug the co-developed by Sanofi and Regeneron Pharmaceuticals, has been approved by the US Food and Drug Administration as an add-on maintenance therapy for two forms of asthma.
Dupixent FDA Approval
The new Dupixent FDA approval is for treating patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.
Dupixent has been designed to inhibit the overactive signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), considered to be two main proteins that contribute to the Type 2 inflammation that may cause moderate-to-severe asthma.
This effect of Dupixent is associated with lowering the levels of inflammatory biomarkers such as fractional exhaled nitric oxide (FeNO), immunoglobulin E (IgE) and eotaxin-3 (CCL26) among others.
Commenting on Dupixent FDA approval for asthma, George D. Yancopoulos – President and Chief Scientific Officer of Regeneron, said: “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.”
Yancopoulos added that Dupixent during the asthma clinical trial program cut down frequency of severe exacerbations and oral corticosteroid use while enhancing quality of life and demonstrating statistically significant and clinically meaningful improvements in lung function.
He further said: “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.”
According to Regeneron Pharmaceuticals, the pivotal asthma clinical trial program assessed 2,888 adult and adolescent patients with moderate-to-severe asthma in three randomized, placebo-controlled, multicenter trials – Trial 1, Trial 2 and Trial 3 for six months to one year.
In Trial 2 , which was the largest trial, Dupixent lowered exacerbations and boosted lung function in the overall population. Benefits in exacerbations were noted in patients with eosinophil counts that were more or equal to 150 cells/microliter, which represented 70% of the enrolled patients.
In Trial 3, which studied severe, oral corticosteroid-dependent patients, Dupixent lowered average daily oral corticosteroid use by 70% in comparison to 42% with placebo. Over half of patients treated with Dupixent totally eliminated use of oral corticosteroids.
Olivier Brandicourt – CEO of Sanofi, commenting on Dupixent FDA approval for asthma, said: “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.
“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. Dupixent has already made a difference for many adults with atopic dermatitis, and we now have the opportunity to do the same for certain adults and adolescents with moderate-to-severe asthma in the U.S.”