First-Ever Biologic Approved for COPD

The FDA approved dupilumab (Dupixent) as the first biologic treatment for adults with chronic obstructive pulmonary disease (COPD), Sanofi and Regeneron announced on Friday.

An injectable interleukin (IL)-4 and IL-13 pathway inhibitor, dupilumab is indicated as an add-on maintenance treatment for inadequately controlled COPD with an eosinophilic phenotype.

Primary support for the approval came from two phase III trials — BOREAS and NOTUS — involving more than 900 COPD patients on maximal inhaled therapy (typically triple therapy) and with blood eosinophil evidence of type 2 inflammation. Both studies met their primary endpoint, with dupilumab as a subcutaneous injection every 2 weeks reducing the annualized rate of moderate or severe COPD exacerbations versus placebo over a year.

In BOREAS, add-on treatment with dupilumab led to a 30% reduction in annual exacerbations (0.78 vs 1.10, respectively; rate ratio [RR] 0.70, 95% CI 0.58-0.86, P<0.001). And in NOTUS, dupilumab maintenance yielded a 34% reduction (0.86 vs 1.30; RR 0.66, 95% CI 0.54-0.82, P<0.001).

Trial data also showed improvements in quality of life and lung function, with numerically greater improvements in post-bronchodilator forced expiratory volume in 1 second (FEV₁) and a significant improvement in pre-bronchodilator FEV₁.

COPD causes progressive declines in lung function and consistently ranks in the top five leading causes of death in the U.S., where an estimated 300,000 adults with COPD have inadequately controlled disease and an eosinophilic phenotype.

“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 statement. “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.”

The most common adverse events with dupilumab in BOREAS and NOTUS (>2%, and occurring more frequently than with placebo) included viral infection, headache, nasopharyngitis, back pain, diarrhea, arthralgia, urinary tract infection, injection site reactions, rhinitis, eosinophilia, toothache, and gastritis. Of note, cholecystitis was reported in more patients on dupilumab than placebo recipients (0.6% vs 0.1%).

Beyond COPD, dupilumab is also approved for atopic dermatitis, asthma, eosinophilic esophagitis, chronic rhinosinusitis, and prurigo nodularis.

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