Dupixent showed ‘strong efficacy’ in the latest trial, showing a 34% reduction in the rate at which patients’ COPD worsened compared to those who received a placebo.
COPD is a chronic obstructive pulmonary disease that damages the lungs over time and causes airflow blockage and breathing-related problems. It is currently the third leading cause of death worldwide.
According to Sanofi, 300,000 people in the US currently have uncontrolled COPD that is identified by an inflammation known as type 2, the focus of the two studies.
The trial included 935 adults who were current or former smokers. In the previous study, known as Boreas, the reduction rate was 30%.
The treatment, developed with Regeneron Pharmaceuticals, is currently approved for several conditions, including asthma and skincare conditions such as atopic dermatitis, and eosinophilic esophagitis.
However, if approved for COPD, it will become the first biologic therapy for the condition – which hasn’t seen any new treatments for over a decade.
“This is the first and only time an investigational biologic in COPD has shown a significant and clinically meaningful reduction in exacerbations in two phase 3 trials, and we are pleased that we can potentially deliver Dupixent faster to patients in need where no new advancements have been identified in over a decade,” said Naimish Patel, head of global development, immunology, and inflammation at Sanofi.
In addition, the US FDA granted breakthrough therapy designation to Dupixent earlier in the year, further emphasising its potential.
Sanofi plans to submit the data from both trials to the US Food and Drug Administration by the end of the year.
If Dupixent is approved as a treatment for COPD, it could advance the medicine into a sizeable new market and add significant revenue to Sanofi’s operations.
