FDA approves Dupixent (dupilumab) to treat chronic obstructive pulmonary disease with an eosinophilic phenotype.- Regeneron + Sanofi
The FDA has approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype, Dupixent is the first biologic medicine approved in the US to treat these patients.
Paul Hudson Chief Executive Officer at Sanofi: “Dupixent has already shown it can revolutionize the treatment paradigm of many diseases driven in part by type 2 inflammation with high unmet medical needs, with one million patients being treated globally across all currently approved indications. With today’s approval, Dupixent once again paves the way and becomes the first and only approved add-on biologic medicine for inadequately controlled COPD, giving patients living with this devastating disease the chance to look forward to the potential of improved breathing and a life with fewer exacerbations.”
The FDA approval is based on data from two landmark pivotal phase III studies (BOREAS and NOTUS) that evaluated the efficacy and safety of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled therapy (nearly all on triple therapy) with inadequately controlled COPD and blood eosinophils greater than 300 cells per uL
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