Dupixent first targeted therapy for COPD approved in EU

EMA concept

The European Medicines Agency (EMA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils.

The approval covers patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS 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, including in the US, China, and Japan.

Tonya Winders, President & CEO of Global Allergy & Airways Patient Platform, said: “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.”

Clinical trial results for Dupixent

The approval is based on results from the Phase III BOREAS and NOTUS studies, which 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).

The trials showed a 30% and 34% reduction in the annualised rate of moderate or severe COPD exacerbations over 52 weeks, the primary endpoint.

There were also improvements in lung function (pre-bronchodilator FEV1) from baseline by 160mL and 139mL at 12 weeks compared to 77mL and 57mL. These improvements were observed as early as week two and four and were sustained at 52 weeks in both studies.

Reductions in exacerbations and improvements in lung function for Dupixent versus placebo were also observed in patients with higher baseline fractional exhaled nitric oxide (≥20ppb) – an airway biomarker of inflammation – and across all pre-defined subgroups including smoking status, baseline lung function, and history of exacerbations.

Safety results in both studies were generally consistent with the known safety profile of Dupixent in its approved indications.

Paul Hudson, Chief Executive Officer at Sanofi, said: “Patients with uncontrolled COPD have been waiting for a new treatment approach for many years, so we are thrilled to bring to market the first biologic to target an underlying cause of this devastating disease to reduce COPD exacerbations and improve lung function. 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.”

Diana Spencer, Senior Digital Content Editor, DDW

Related Articles

Join FREE today and become a member
of Drug Discovery World

Membership includes:

  • Full access to the website including free and gated premium content in news, articles, business, regulatory, cancer research, intelligence and more.
  • Unlimited App access: current and archived digital issues of DDW magazine with search functionality, special in App only content and links to the latest industry news and information.
  • Weekly e-newsletter, a round-up of the most interesting and pertinent industry news and developments.
  • Whitepapers, eBooks and information from trusted third parties.
Join For Free