FDA Priority Review for Dupixent's COPD Treatment

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The supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment for adult patients with uncontrolled chronic obstructive pulmonary disease (COPD) has been accepted for Priority Review by the US Food and Drug Administration (FDA). The FDA decision is expected to be made by June 27, 2024, while regulatory submissions in China and the European Union are also under review.

The efficacy and safety of Dupixent in adults with a smoking history and uncontrolled COPD with type 2 inflammation (blood eosinophils >300 cells/microliter) was evaluated in a phase 3 COPD clinical research program.

All patients received maximal standard-of-care inhaled therapy, with primary endpoints met in both trials (BOREAS, NOTUS), showing that Dupixent significantly reduced moderate or severe acute COPD exacerbations by 30% and 34%, respectively, compared to placebo. Furthermore, Dupixent rapidly improved lung function, with improvements sustained at 52 weeks.

The safety profile of Dupixent in its approved indications was consistent with the safety results of both trials. Adverse events observed with Dupixent (=5%) compared to placebo in either trial were back pain, Covid-19, diarrhea, headache, and nasopharyngitis.

Priority Review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvement in the treatment, diagnosis, or prevention of serious conditions. No regulatory authority has fully evaluated the safety and efficacy of Dupixent for COPD.

COPD is a progressive respiratory disease that damages the lungs, causing symptoms such as persistent cough, breathlessness, and excessive mucus production. These symptoms can impair daily activities and cause anxiety, depression, and sleep disturbances.

COPD is associated with a significant health and economic burden due to recurrent acute exacerbations that may require systemic corticosteroid treatment and hospitalization. Smoking and exposure to toxic particles are key risk factors for COPD, with approximately 300,000 people living with uncontrolled COPD and type 2 inflammation in the US. No new treatment approaches have been approved for more than a decade.