Sanofi and Regeneron’s Dupixent (dupilumab) has been recommended by the European Medicines Agency’s human medicines committee as an add-on maintenance treatment for chronic obstructive pulmonary disease (COPD).
The positive opinion from the Committee for Medicinal Products for Human Use (CHMP) specifically applies to adults with uncontrolled COPD characterised by raised blood eosinophils.
COPD, a chronic respiratory disease that causes progressive lung function decline, is the fourth leading cause of death worldwide.
Symptoms include a persistent cough, excessive mucus production and a shortness of breath that may impair the ability to perform routine daily activities.
Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 pathways, shown in the Dupixent development programme to be central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases.
If approved by the European Commission, Dupixent would be the first-ever targeted therapy for COPD in the EU and the first new treatment approach for the disease in more than a decade.
The recommendation from the CHMP, which will be reviewed by the EU regulator, is supported by positive results from the late-stage BOREAS and NOTUS trials of Dupixent in adults with uncontrolled COPD and evidence of type 2 inflammation.
The primary endpoint was met in both studies, with Dupixent shown to significantly reduce annualised moderate or severe acute COPD exacerbations compared to placebo.
Improvements in lung function in Dupixent-treated patients were sustained at 52 weeks and the therapy was also shown to improve health-related quality of life at 52 weeks, as assessed by the St. George’s Respiratory Questionnaire.
A co-principal investigator of the NOTUS study, Surya Bhatt, the University of Alabama at Birmingham, said earlier this month: “In NOTUS, [Dupixent] reduced exacerbations by a magnitude never seen before with an investigational biologic in a phase 3 COPD clinical study.
“These comprehensive results reinforce that, if approved, [Dupixent] could provide a first-of-its-kind medical advancement for the COPD community.”
Dupixent already holds approvals for a range of indications, including for certain patients with atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis.
Regulatory submissions for use of the therapy in COPD are under review with other regulatory authorities around the world, including the US and China.