and announced positive results from the phase 3 trial which evaluated Dupixent (dupilumab) in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. The trial met its primary and all key secondary endpoints. Based on this data, U.S. and EU regulatory submissions for children aged 6-11 years are planned for filing by Q1 2021.
LIBERTY ASTHMA VOYAGE was a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Dupixent in addition to standard-of-care maintenance therapy of medium-dose inhaled corticosteroid (ICS) with a second controller medication or high-dose ICS with or without a second controller medication. The trial enrolled 408 children aged 6 to <12 years old with uncontrolled moderate-to-severe asthma. During the 52-week treatment period, patients received subcutaneous injections of Dupixent 100 mg or 200 mg every two weeks, based on weight (100 mg for â¤30 kg, 200 mg for >30 kg), or placebo every two weeks.
The primary endpoint assessed the annualized rate of severe asthma attacks in two primary pre-specified population: patients with baseline elevated eosinophils (EOS) â¥300 cells/Âµl and patients with markers of type 2 inflammation (baseline EOS â¥150 cells/Î¼l or FeNO â¥20 ppb).
Dupixent reduced rate of severe asthma attacks, with a 65% and 59% average reduction over one year compared to placebo (0.24 and 0.31 events per year for Dupixent vs. 0.67 and 0.75 for placebo, respectively). Treatment with Dupixent also improved lung function at 12 weeks compared to baseline by 10.15 and 10.53 percentage points for Dupixent vs. 4.83 and 5.32 percentage points for placebo, respectively, as measured by percent predicted FEV1 (FEV1p).
Over one year overall rates of adverse events were 83% for Dupixent and 80% for placebo. Adverse events that were most commonly observed with Dupixent versus placebo included injection site reactions, viral upper respiratory tract infections and eosinophilia.
Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, that was invented using Regeneron’s proprietary VelocImmuneÂ® technology. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), atopic dermatitis and eosinophilic esophagitis.
Moderate to Severe Uncontrolled Asthma in Children
Children with uncontrolled moderate-to-severe asthma who receive standard of care such as inhaled corticosteroids (ICS), often continue to experience symptoms such as coughing, wheezing and difficulty breathing, and are at risk of severe asthma attacks. For these children, this can result in frequent hospitalizations and emergency room visits requiring use of systemic corticosteroids which can carry significant risks when used long term. Uncontrolled asthma can cause children to miss school and can interfere with physical activity and routine tasks such as walking up stairs and playing sports. In the U.S., there are approximately 75,000 children 6-11 years old with uncontrolled moderate-to-severe asthma.