The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with poorly controlled chronic obstructive pulmonary disease (COPD) and high counts of immune cells called eosinophils. Elevated eosinophils are a marker of type 2 inflammation, which is thought to contribute…

Dupixent (dupilumab) has been approved by the European Commission as an add-on maintenance treatment for certain adults with uncontrolled chronic obstructive pulmonary disease (COPD). Specifically, the therapy from Sanofi and Regeneron Pharmaceuticals is now indicated for COPD patients in the European Union who have evidence of type…

Dupixent (dupilumab) as an add-on maintenance treatment significantly eased exacerbations and lung symptom severity while improving lung function and quality of life — among people with moderate to severe chronic obstructive pulmonary disease (COPD). That’s according to published data from the Phase 3 NOTUS clinical trial (NCT04456673), which…

The U.S. Food and Drug Administration (FDA) has delayed by three months its decision about whether to approve Dupixent (dupilumab) as an add-on treatment for certain adults with chronic obstructive pulmonary disease (COPD). A decision is now expected by Sept. 27. An initial call was due at the…

The U.S. Food and Drug Administration (FDA) has asked for more data from clinical trials that tested Dupixent (dupilumab) in people with chronic obstructive pulmonary disease (COPD), Regeneron Pharmaceuticals, one of the therapy’s developers, announced during a company webcast. The requested data pertains to subgroup analyses from two…

The U.S. Food and Drug Administration has agreed to review Sanofi and Regeneron Pharmaceuticals’ request for a label extension for Dupixent (dupilumab) to include it as an add-on treatment for certain adults with uncontrolled chronic obstructive pulmonary disease (COPD). The therapy’s potential sixth indication in the U.S.

Treatment with Dupixent (dupilumab) — approved in the U.S. for five inflammatory conditions, to date — once again resulted in significantly fewer exacerbations, or periods of sudden symptom worsening, among people with moderate to severe chronic obstructive pulmonary disease (COPD) in the second of two similarly designed Phase 3…

Dupixent (dupilumab) — a medication initially approved for exzema — was found to significantly reduce the number of disease exacerbations and to improve lung function in people with chronic obstructive pulmonary disease (COPD), meeting the primary and key secondary goals of the pivotal Phase 3 BOREAS trial. A similarly…