FDA Approves Dupixent as First Biologic Treatment for COPD
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL4 and IL13 pathways.
The FDA has approved dupilumab (Dupixent) as an add-on maintenance treatment for adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype, Sanofi announced in a release.1 The decision makes dupilumab the first biologic medicine approved in the United States to treat the lung disease.
FDA Approves Dupixent as First Biologic Treatment for COPD / Tada Images - stock.adobe.com
The approval of dupilumab was based on data from 2 phase 3 studies, BOREAS (NCT03930732) and NOTUS (NCT04456673), in which the therapy met its primary endpoint of the annualized rate of moderate or severe COPD exacerbations over 52 weeks. The therapy also met key secondary endpoints, including change in pre-bronchodilator FEV1, change in Saint George's Respiratory Questionnaire (SGRQ) total score at Week 52, and improvement in SGRQ.
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“People living with inadequately controlled COPD have long awaited new medicines to help manage the daily suffering they experience from breathlessness, coughing, wheezing, exhaustion and unpredictable hospitalization,” Jean Wright, MD, CEO of the COPD Foundation, said in a release.1 “These patients often struggle with everyday activities many people take for granted such as taking a walk or running errands outside the home. We welcome the approval of this new therapeutic option to offer patients a new way to help gain better control of their disease.”
BOREAS was a randomized, double-blind, placebo-controlled, parallel-group phase 3 study that evaluated the efficacy, safety and tolerability of dupilumab in patients with moderate to severe COPD with type 2 inflammation. The study cohort included 939 patients who were current or former smokers aged 40 to 80 years. Patients randomly received dupilumab or placebo every 2 weeks for 52 weeks.
The study found that dupilumab resulted in a 30% reduction of moderate or severe acute COPD exacerbations over the study period compared to placebo. The therapy also improved lung function by 160 mL at 12 weeks, compared to 77 mL for placebo. The improvement was also sustained through week 52. Dupilumab’s safety was consistent with its known profile, with the most common adverse events being headache, diarrhea and back pain.2
NOTUS was a randomized, double-blind, placebo-controlled, parallel-group phase 3 study that evaluated the efficacy, safety and tolerability of dupilumab in patients with moderate to severe COPD with type 2 inflammation. The study cohort included 935 patients who were current or former smokers aged 40 to 85 years. Patients randomly received dupilumab or placebo every 2 weeks for 52 weeks.
The study found that that dupilumab resulted in a 34% reduction of moderate or severe acute COPD exacerbations over the study period compared to placebo. The therapy also improved lung function by 139 mL at 12 weeks, compared to 57 mL for placebo. Dupilumab’s safety was consistent with its known profile, with the most common adverse events being COVID-19, nasopharyngitis and headache.3
Dupilumab, which was codeveloped with Regeneron, is a fully human monoclonal antibody that inhibits the signaling of the IL4 and IL13 pathways. It is currently approved in the US to treat eczema in adults and children 6 months and older, asthma in adults and children aged 6 and older, chronic rhinosinusitis with nasal polyps in adults and children aged 12 and older, eosinophilic esophagitis in adults and children aged 1 and older, and prurigo nodularis in adults.
“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 1 million patients being treated globally across all currently approved indications,” Paul Hudson, CEO of Sanofi, said in a release.1 “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.”
READ MORE: Respiratory Resource Center
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