EMA Approves Dupixent for Adult COPD Treatment

The European Medicines Agency (EMA) has granted approval to Sanofi's Dupixent (dupilumab) as the first targeted therapy for adults suffering from uncontrolled chronic obstructive pulmonary disease (COPD) characterized by elevated blood eosinophils. This authorization is intended for patients who are on a regimen that includes a combination of inhaled corticosteroid (ICS), long-acting beta2-agonist (LABA), and long-acting muscarinic antagonist (LAMA), or a combination of LABA and LAMA when ICS is unsuitable.

The approval of Dupixent is based on the results from the Phase III BOREAS and NOTUS clinical trials. These studies evaluated the efficacy and safety of Dupixent in adults with uncontrolled COPD and evidence of type 2 inflammation. The treatment demonstrated significant reductions in COPD exacerbations and notable improvements in lung function among the participants.

Patients treated with Dupixent experienced a 30% and 34% reduction in the frequency of moderate or severe COPD exacerbations over a period of 52 weeks compared to those who received a placebo. Improvements in lung function were noticeable as early as two to four weeks after the initiation of treatment and were maintained throughout the 52-week period.

Furthermore, patients reported improvements in health-related quality of life, with these enhancements being statistically significant. The benefits of Dupixent were consistent across various subgroups, including individuals with different smoking statuses, baseline lung functions, and histories of exacerbations. The safety profile of Dupixent observed in these studies was consistent with its known safety data from other approved uses.

Sanofi CEO Paul Hudson remarked on the approval, stating, “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 addition to the European approval, Dupixent is currently under review by other regulatory authorities in the United States, China, and Japan.

In June 2024, Sanofi announced a collaboration with Biovac to establish the first African-based manufacturing capabilities for inactivated polio vaccines, signifying a strategic move to enhance vaccine production on the continent. This development underscores Sanofi's commitment to expanding global access to essential medicines and vaccines.

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