European Union approves Dupixent

Map of the European Union.

Coming on the heels of the U.S. approval of ensifentrine for COPD, the European Union has granted a first in the world approval for another weapon for treating adults with uncontrolled COPD: Dupixent.

The European Medicines Agency (EMA) has approved Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD characterized by raised blood eosinophils. Specifically, the approval covers patients already on a combination of an inhaled corticosteroid, a long-acting beta2-agonist and a long-acting muscarinic antagonist, or a combination of the last two if the inhaled corticosteroid is not appropriate.

The EMA is the first regulatory authority in the world to approve Dupixent for COPD patients. Additional submissions are under review with other regulatory authorities around the world, including the U.S., China and Japan.

Tonya Winders, president and CEO of the Global Allergy & Airways Patient Platform, praised the approval as a big step forward in the treatment of COPD.

“After more than a decade of limited treatment advancements for those living with uncontrolled COPD, we are now in a new era of disease management for patients and caregivers, and we welcome the addition of innovative, new treatments such as Dupixent to help manage this progressive and irreversible disease,” she said.

The approval is based on results from the landmark phase 3 BOREAS and NOTUS studies, which were separately published in The New England Journal of Medicine. The two clinical trials evaluated the efficacy and safety of Dupixent in adults with uncontrolled COPD with evidence of type 2 inflammation (i.e., blood eosinophils ≥300 cells per μL). All patients were on background maximal standard-of-care inhaled therapy (with nearly all on triple therapy).

In terms of efficacy, Dupixent patients experienced the following outcomes compared to placebo patients, respectively:

  • A 30% (in the BOREAS study) and 34% (in the NOTUS study) reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks, the primary endpoint.
  • Improvements in lung function (pre-bronchodilator FEV1) from baseline by 160 mL and 139 mL at 12 weeks compared to 77 mL and 57 mL. These improvements were observed as early as week 2 and 4 and were sustained at 52 weeks in both studies.
  • Improvements in health-related quality of life (statistically significant in BOREAS and nominally significant in NOTUS), as assessed by the St. George’s Respiratory Questionnaire.
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