Approvals

The US Food and Drug Administration has approved Sanofi’s Dupixent as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.

Indicated for 300,000 adults, Dupixent is the first biologic medicine to be approved in the US for patients with COPD. It is a fully human monoclonal antibody (mAb) that inhibits the signalling of the IL4 and IL13 pathways – two of the key drivers of type 2 inflammation – while not being an immunosuppressant.

The approval was based on data from the BOREAS and NOTUS phase 3 studies, which evaluated the efficacy and safety of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled therapy. The studies enrolled 1,874 patients who were aged 40-80 years in BOREAS and 40-85 years in NOTUS: they found a 30% and 34% reduction in the annualised rate of moderate or severe COPD exacerbations over 52 weeks (the primary endpoint), and a 51% response in a health-related quality of life measure in both trials compared to 43% and 47% with placebo at 52 weeks, as assessed by a 4-point improvement on the St George’s Respiratory Questionnaire (SGRQ).

Paul Hudson, CEO at Sanofi, stated: “Dupixent has already shown it can revolutionise the treatment paradigm of many diseases driven in part by type 2inflammation 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.”