Regeneron Pharmaceuticals and Sanofi have received the European Commission (EC) approval for Dupixent (dupilumab) to treat adults with uncontrolled chronic obstructive pulmonary disease (COPD).
Dupixent has been approved in the European Union (EU) as an add-on maintenance treatment for COPD characterised by increased blood eosinophils.
Specifically, the approval applies to patients currently using a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA).
The fully human monoclonal antibody can also be used for patients on a combination of LABA and LAMA when ICS is not suitable.
Dupilumab is jointly developed by US biotechnology firm Regeneron and French pharmaceutical company Sanofi, under a global collaboration agreement.
The European Medicines Agency (EMA) of the EC becomes the first regulatory body to authorise Dupixent for COPD patients.
In 2019, Dupixent was approved by the EC to treat severe asthma with type 2 inflammation in adults and adolescents 12 years and older.
Regeneron board co-chair, president and chief scientific officer George Yancopoulos said: “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 on exacerbations and lung function, as well as improving health-related quality of life across two large Phase 3 trials.”
The approval is supported by findings from the Phase 3 BOREAS and NOTUS trials.
These studies assessed the effectiveness and safety of Dupixent in adults with uncontrolled COPD showing evidence of type 2 inflammation.
According to the results, Dupixent patients in the BOREAS and NOTUS trials showed a 30% and 34% reduction, respectively, in the annualised rate of moderate or severe COPD exacerbations, which was the primary endpoint.
The drug also showed improvements in lung function from baseline by 160 mL and 139 mL at 12 weeks, compared to 77 mL and 57 mL with placebo.
These improvements were noticeable as early as weeks two and four and were sustained through 52 weeks in both trials.
Safety findings in both trials generally aligned with Dupixent’s established safety profile in its approved indications.
The human monoclonal antibody is under assessment for COPD by regulatory authorities in other countries, including the US, China, and Japan.
Sanofi CEO Paul Hudson said: “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.”
