Saturday, July 13, 2024

Chronic Obstructive Pulmonary Disease Treatment Dupixent Approval by European Commission Marks New Era

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Regeneron Pharmaceuticals and Sanofi announced that the European Commission (EC) has approved Dupixent® (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. The approval covers patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate. The EC is the first regulatory authority in the world to approve Dupixent for chronic obstructive pulmonary disease patients, with additional submissions under review in the U.S., China, and Japan.

Tonya Winders, President and CEO at Global Allergy & Airways Patient Platform, expressed optimism, stating, “As a progressive and devastating disease, COPD leads to suffering from breathlessness that limits a person’s ability to conduct everyday activities. Many patients feel marginalized and isolated because of the physical and mental toll of the disease. After more than a decade of limited treatment advancements for those living with uncontrolled chronic obstructive pulmonary disease, we are now in a new era of disease management for patients and caregivers, and we welcome the addition of innovative, new treatments such as Dupixent to help manage this progressive and irreversible disease.”

George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron, remarked, “The approval of Dupixent for chronic obstructive pulmonary disease is a long-awaited turning point for those who struggle to breathe even through the simplest of tasks. With this approval, we are proud that Dupixent has the potential to redefine the treatment landscape in yet another disease, as a first-in-class therapy demonstrating unprecedented improvements in exacerbations and lung function, as well as improving health-related quality of life across two large Phase 3 trials.”

Phase 3 Trials Confirm Dupixent’s Effectiveness for Uncontrolled Chronic Obstructive Pulmonary Disease

The approval is based on results from the landmark Phase 3 BOREAS and NOTUS trials, published in the New England Journal of Medicine. The trials evaluated the efficacy and safety of Dupixent in adults with uncontrolled chronic obstructive pulmonary disease with evidence of type 2 inflammation (i.e., blood eosinophils ≥300 cells per μL). All patients were on background maximal standard-of-care inhaled therapy.

In the trials, Dupixent patients experienced a 30% and 34% reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks, improved lung function from baseline by 160 mL and 139 mL at 12 weeks, and sustained improvements at 52 weeks. The treatment also improved health-related quality of life, as assessed by the St. George’s Respiratory Questionnaire (SGRQ). Reductions in exacerbations and improvements in lung function were observed in patients with higher baseline fractional exhaled nitric oxide (FeNO; ≥20ppb) and across all predefined subgroups, including smoking status, baseline lung function, and history of exacerbations.

Safety results in both trials were consistent with the known safety profile of Dupixent in its approved indications. The most common side effects included injection site reactions, conjunctivitis, arthralgia, oral herpes, and eosinophilia. Adverse events more commonly observed with Dupixent compared to placebo included back pain, COVID-19, diarrhea, headache, and nasopharyngitis.

Chronic Obstructive Pulmonary Disease

Announcing Landmark Approval of Dupixent for Chronic Obstructive Pulmonary Disease in the EU

Paul Hudson, CEO at Sanofi, emphasized, “Patients with uncontrolled COPD have been waiting for a new treatment approach for many years. We are thrilled to bring to market the first biologic to target an underlying cause of this devastating disease to reduce COPD exacerbations and improve lung function. With today’s approval of Dupixent, we can change the treatment landscape for the more than 200,000 patients throughout the EU living with uncontrolled chronic obstructive pulmonary disease with raised blood eosinophils. We look forward to working with other regulators around the world to bring this novel treatment approach to patients in more countries.”

COPD is a respiratory disease that damages the lungs and causes progressive lung function decline, making it the fourth leading cause of death worldwide. Symptoms include persistent cough, excessive mucus production, and shortness of breath, which impair daily activities and can lead to sleep disturbances, anxiety, and depression. Chronic obstructive pulmonary disease is associated with significant health and economic burdens due to recurrent acute exacerbations requiring systemic corticosteroid treatment and/or hospitalization. Despite quitting smoking, individuals can still develop or continue having the disease, and no new treatment approaches have been approved for over a decade.

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The BOREAS and NOTUS trials were replicate, randomized, Phase 3, double-blind, placebo-controlled trials that evaluated the efficacy and safety of Dupixent in adults who were current or former smokers with moderate-to-severe chronic obstructive pulmonary disease with evidence of type 2 inflammation. The trials enrolled 1,874 patients aged 40 to 80 years in BOREAS and 40 to 85 years in NOTUS. During the 52-week treatment period, patients received Dupixent or placebo every two weeks added to a maximal standard-of-care inhaled triple therapy of ICS, LABA, and LAMA.

The primary endpoint was the annualized rate of moderate or severe COPD exacerbations, with key secondary endpoints including change from baseline in lung function at 12 and 52 weeks, change from baseline at 52 weeks in SGRQ total score compared to placebo, and safety.

 

Resource: Regeneron, July 03, 2024

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