The European Medicines Agency (EMA) has approved Sanofi‘s Dupixent (dupilumab) as the first targeted therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils.
This authorisation is specifically for patients receiving a combination of inhaled corticosteroid (ICS), long-acting beta2-agonist (LABA) and long-acting muscarinic antagonist (LAMA), or on LABA and LAMA if ICS is unsuitable.
Dupixent’s approval is supported by the findings from the Phase III BOREAS and NOTUS studies.
These trials assessed the efficacy and safety of Dupixent in adult patients with uncontrolled COPD with evidence of type 2 inflammation.
The treatment with Dupixent was demonstrated to offer significant reductions in COPD exacerbations and improvements in lung function among patients.
Compared to placebo groups, Dupixent patients saw 30% and 34% reductions in their rate of moderate or severe COPD exacerbations over 52 weeks.
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Lung function improvements were evident from as early as two to four weeks and were sustained at 52 weeks.
Patients treated with Dupixent also reported enhancements in health-related quality of life, with statistically significant results.
Benefits were consistent across subgroups, including those with different smoking statuses, baseline lung functions, and histories of exacerbations.
The safety profile of Dupixent in these studies aligned with its known safety data from other approved indications.
The asset is also under review by other regulatory authorities, including those in the US, China and Japan.
Sanofi CEO Paul Hudson stated: “With the approval of Dupixent, we can change the treatment landscape for the more than 200,000 patients throughout the European Union living with uncontrolled COPD with raised blood eosinophils.”
In June 2024, Sanofi announced a partnership with Biovac to establish the first African-based manufacturing capabilities for inactivated polio vaccines.
