Regeneron, Sanofi: EU Approves Dupixent As First-ever Targeted Therapy For COPD Patients

(RTTNews) - Drug makers Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNY) announced Wednesday that the European Commission has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease or COPD characterized by raised blood eosinophils.

Dupixent has been approved in the European Union as the first-ever targeted therapy for patients with COPD, a respiratory disease. The EC is the first regulatory authority in the world to approve Dupixent for adults with uncontrolled COPD with raised blood eosinophils. The companies noted that additional submissions are under review with other regulatory authorities around the world, including in the U.S., China and Japan.

The EU approval was based on two landmark Phase 3 BOREAS and NOTUS trials. The data showed that Dupixent significantly reduced exacerbations, improved lung function and also improved health-related quality of life.

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

Regeneron and Sanofi said the approval covers patients already on a combination of an inhaled corticosteroid or ICS, a long-acting beta2-agonist or LABA and a long-acting muscarinic antagonist or LAMA, or on a combination of a LABA and a LAMA if ICS is not appropriate.

Paul Hudson, Chief Executive Officer at Sanofi, said, "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. We look forward to working with other regulators around the world as quickly as possible to bring this novel treatment approach to patients in more countries."

The latest approval represents the sixth approved indication for Dupixent in the EU and seventh approved indication globally.

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