- Only biologic approved for both moderate and severe asthma patients with eosinophilic phenotype
- Only biologic approved for oral corticosteroid-dependent asthma, regardless of phenotype
- Only asthma biologic that offers patient self-administration at home
- Only asthma biologic also approved for adult patients with moderate-to-severe atopic dermatitis, a Type 2 inflammatory disease driven by the IL-4 and IL-13 pathway
- In clinical trials, Dupixent reduced severe exacerbations and oral corticosteroid use and improved lung function
PARIS and TARRYTOWN, NY – October 19, 2018 – The U.S. Food and Drug Administration has approved Dupixent® (dupilumab) as an 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.
Dupixent inhibits the overactive signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that contribute to the Type 2 inflammation that may underlie moderate-to-severe asthma. This effect is associated with the reduction of inflammatory biomarkers including fractional exhaled nitric oxide (FeNO), immunoglobulin E (IgE) and eotaxin-3 (CCL26).
“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,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. “In the asthma clinical trial program, Dupixent reduced severe exacerbations and oral corticosteroid use, improved quality of life and showed statistically significant and clinically meaningful improvements in lung function. 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.”
“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,” said Olivier Brandicourt, M.D., Chief Executive Officer, Sanofi. “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.”
Patients with moderate-to-severe asthma often have uncontrolled, persistent symptoms despite standard-of-care therapy that may make them suitable for treatment with a biologic therapy. They live with coughing, wheezing and difficulty breathing, and are at risk of severe asthma attacks that may require emergency room visits or hospitalizations., Oral corticosteroids can provide relief for severe, short-term symptoms. However, their chronic use is limited to the most severe patients due to the potential for serious side effects.,
“Despite being compliant with their current medicine, many people with moderate-to-severe asthma, including those with eosinophilic phenotype or with oral steroid dependence, live with persistent symptoms like unpredictable attacks and difficulty breathing,” said Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America (AAFA). “AAFA supports the availability of innovative new treatment options for people with asthma who struggle with uncontrolled symptoms that impair their quality of life.”
For people with asthma, Dupixent comes in two doses (200 mg and 300 mg) given every other week at different injection sites after an initial loading dose.
Efficacy and safety results from the pivotal clinical trial program
The pivotal trial program evaluated 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 (24 to 52 weeks). All trials enrolled patients irrespective of minimum baseline eosinophil levels.
In Trial 2 (the largest trial), Dupixent reduced exacerbations and improved lung function in the overall population. Benefits in exacerbations were seen in patients with eosinophil counts greater than or equal to 150 cells/microliter, which represented 70% of the patients enrolled. Efficacy improved in patients with higher eosinophil counts. For example, in patients with blood eosinophils of 300 cells/microliter or greater, Dupixent reduced severe exacerbations by 67% compared to placebo and improved FEV1 (lung function) by 29%-33% compared to 14%-16% for placebo. In patients with eosinophil counts less than 150 cells/microliter, there was no difference in severe exacerbation rates for Dupixent versus placebo.
In Trial 3, which evaluated severe, oral corticosteroid-dependent patients, Dupixent reduced average daily oral corticosteroid use by 70% compared to 42% with placebo. More than half of patients treated with Dupixent completely eliminated use of oral corticosteroids. Effects on lung function and on oral steroid and exacerbation reduction were similar for Dupixent irrespective of baseline blood eosinophil levels.
In the asthma clinical trials, the adverse reactions that occurred with Dupixent at a rate of at least 1% and more frequently than the respective comparator were injection site reactions, sore throat, and an increase in the number of eosinophils, a type of white blood cell, in the blood.