First approval of Dupixent for COPD patients (Il Sole 24 Ore Radiocor) - Paris, 03 Jul - French pharmaceutical company Sanofi said that the European Medicines Agency (EMA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized 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 around the world, including in the US, China, and Japan.

The approval is based on results from the landmark phase 3 BOREAS and NOTUS studies that showed a 30% and 34% reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks, the primary endpoint. They also showed improvements in lung function and the health-related quality of life.

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(RADIOCOR) 03-07-24 12:02:48 (0322) 5 NNNN