Dupixent (Dupilumab) Gets FDA Approval for Lung Disease COPD

The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) injections as an add-on therapy for certain adults with poorly controlled chronic obstructive pulmonary disease (COPD).

The FDA cleared Dupixent for people with COPD who are also using inhaled COPD medications yet still have too many eosinophils. An important part of the immune system, eosinophils are a type of white blood cell that can cause inflammation in the lungs and exacerbate breathing problems. Dupixent is an “add-on” maintenance therapy that these patients can take in addition to inhaled medicines, said the drug’s maker, Sanofi, in a statement.

Dupixent is a biologic drug, a newer class of medication made from living cells or components of living organisms, like proteins. It works by targeting parts of the immune system that contribute to chronic inflammatory diseases.

 Sanofi says Dupixent is the first-ever biologic for COPD.

“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, the chief executive officer at the COPD Foundation, said in the drugmaker’s statement.

“These patients often struggle with everyday activities many people take for granted, such as taking a walk or running errands outside the home,” Dr. Wright said in the statement. “We welcome the approval of this new therapeutic option to offer patients a new way to help gain better control of their disease.”

When Inhaled Medications Aren’t Doing Enough for COPD

People with COPD suffer from conditions that restrict the flow of air in the lungs and make it difficult to breathe. Most people have either emphysema, which happens when air sacs in the lungs called alveoli don’t function properly, or chronic bronchitis — which happens when inflammation in the airways causes mucus to accumulate in the lungs.