HQ Team
July 4, 2024: The European Medicines Agency has approved Sanofi S.A.’s Dupixent (dupilumab) therapy as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease, according to a company statement.
The treatment for the disease, in which the patients have high blood eosinophils, involves a combination of an inhaled corticosteroid and two antagonists — a beta2-agonist and a muscarinic one.
Beta2-agonists replicate the functions of catecholamines such as dopamine, that are important in stress and automatic responses within the body. Abnormal levels of catecholamines cause high blood pressure which can lead to headaches, sweating, pounding of the heart, pain in the chest, and anxiety.
The best2-agonists are used as a mainstay treatment for respiratory diseases such as bronchial asthma and chronic obstructive pulmonary disease.
34% reduction
The smooth muscle of the airway, uterus, intestine, and systemic vasculature are areas where beta-2 agonists have the greatest effect. Muscarinic relates to imitating the action of muscarine on neurons, especially in blocking cholinergic effects.
The EU approval was based on end-stage results from a trial in which 30% and 34% reduction were observed in the annualised rate of moderate or severe COPD exacerbations over 52 weeks. The studies enrolled 1,874 patients aged between 40 to 85 years.
The Paris-headquartered Sanofi stated that submissions for approval were under review with other regulatory authorities, including in the US, China, and Japan.
Dupilumab is jointly developed by Sanofi and Regeneron under a global collaboration agreement.
3.23 million deaths in 2019
Chronic obstructive pulmonary disease (COPD) is a common lung disease causing restricted airflow and breathing problems. It is sometimes called emphysema or chronic bronchitis.
It is the third leading cause of death worldwide, causing 3.23 million deaths in 2019, according to the WHO. Nearly 90% of COPD deaths in those under 70 years of age occur in low- and middle-income countries.
Tobacco smoking accounts for over 70% of the cases in high-income countries. In low- and middle-income countries tobacco smoking accounts for between 30% and 40% of COPD cases, and household air pollution is a major risk factor.
“As a progressive and devastating disease, COPD leads to suffering from breathlessness that limits a person’s ability to conduct everyday activities such as walking up the stairs or to the mailbox,” said Tonya Winders, President & CEO of Global Allergy & Airways Patient Platform.
“Many patients feel marginalized and isolated because of the physical and mental toll of the disease,” she said.
Not curable
The disease is not curable but symptoms can improve if one avoids smoking and exposure to air pollution and gets vaccines to prevent infections. It can also be treated with medicines, oxygen and pulmonary rehabilitation, according to the WHO.
“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 COPD with raised blood eosinophils,” said Paul Hudson, Chief Executive Officer at Sanofi.
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 polyposis, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, and COPD in different age populations.
To date, dupilumab has been studied across more than 60 clinical studies involving more than 10,000 patients with various chronic diseases driven in part by type-2 inflammation.
