HQ Team
September 29, 2024: Regeneron Pharmaceuticals and Sanofi’s drug, Dupixent, got the US regulator’s approval to treat patients with chronic obstructive pulmonary disease.
The drug, dupilumab, branded as Dupixent, will be an add-on maintenance treatment for adults with inadequately controlled lung disease.
It can also treat an eosinophil disorder, where a white blood cell measure (more than 300 cells per microliter) indicates the presence of allergies, parasites, or cancer, according to a joint statement.
The approval from the Food and Drug Administration was based on data from two end-stage trials on 1,874 patients that evaluated the efficacy and safety of Dupixent compared to a dummy drug in adults.
52% improvement in quality of life
The placebo drug patients were treated with maximal standard-of-care inhaled therapy and a high blood eosinophils count.
Dupixent data showed a 30% and 34% reduction in the annualized rate of moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations over 52 weeks — the primary endpoint.
It also demonstrated a 51% response in health-related quality of life study in the trials compared to 43% and 47% with placebo at 52 weeks.
The US drug regulator evaluated Dupixent under Priority Review — reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.
In July 2024, Regeneron and Sanofi announced the European Commission approved Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD characterized by raised blood eosinophils.
Dupixent is jointly developed by Sanofi and Regeneron under a global collaboration agreement.
Approved in 60 countries
Submissions are currently under review with other regulatory authorities worldwide, including Japan.
Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis and chronic spontaneous urticaria.
More than 1,000,000 patients are being treated with Dupixent globally, according to the statement.
“People living with inadequately controlled COPD have long awaited new medicines to help manage the daily suffering they experience from breathlessness, coughing, wheezing, exhaustion and unpredictable hospitalization,” said Jean Wright, MD, Chief Executive Officer at the COPD Foundation.
“These patients often struggle with everyday activities many people take for granted such as taking a walk or running errands outside the home,” she said.
Persistent cough
The respiratory disease damages the lungs and causes progressive lung function decline and is the fourth leading cause of death worldwide.
Symptoms include persistent cough, excessive mucus production and shortness of breath that may impair the ability to perform routine daily activities, which may lead to sleep disturbances, anxiety and depression.
Smoking and exposure to air pollution and occupational hazards are key risk factors for COPD, but even individuals who quit smoking can still have progressive lung disease.
About half of COPD patients continue to experience exacerbations despite being on triple inhaled therapy.
In the US about 300,000 people live with inadequately controlled COPD and an eosinophilic phenotype.
Patients with an eosinophilic phenotype contribute to a more than 30% increase in exacerbations and an increased risk of COPD-related re-hospitalizations within a year.
