Sanofi, Regeneron's Dupixent earns first COPD approval in EU

Sanofi and Regeneron’s Dupixent (dupilumab) has received approval in Europe for use as an add-on maintenance treatment for adults suffering from uncontrolled chronic obstructive pulmonary disease (COPD). This is the first time the drug has been approved for this particular indication. Paul Hudson, the CEO of Sanofi, highlighted the significance of this approval by noting that Dupixent is the “first biologic to target an underlying cause” of COPD. The biologic aims to reduce exacerbations and improve lung function in patients.

The approval was largely based on the results from the Phase III BOREAS and NOTUS studies. In these studies, Dupixent demonstrated notable efficacy by reducing the annualized rate of moderate or severe COPD exacerbations by 30% and 34% over 52 weeks, respectively. Additionally, the drug showed improvements in lung function, with baseline increases of 160 mL and 139 mL after 12 weeks of treatment.

In the European Union, Dupixent is approved for use in patients who are already receiving a combination therapy of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA). It is also approved for those on a combination of a LABA and a LAMA if ICS treatment is not suitable.

Dupixent functions by inhibiting the signaling pathways of interleukin-4 (IL-4) and interleukin-13 (IL-13), which are involved in the inflammatory process. The drug was anticipated to receive approval from the U.S. Food and Drug Administration (FDA) for the treatment of COPD earlier in the year. However, the FDA extended its review period by three months to September 27 to allow for additional efficacy analysis, particularly focusing on subpopulations, from the BOREAS and NOTUS trials.

Last year, Dupixent generated significant sales, amounting to €10.7 billion ($11.6 billion). The drug’s new approval for COPD adds to its portfolio and is expected to contribute further to its commercial success.