The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype.
Sanofi, the co-manufacturer of Dupixent along with Regeneron, said in a news release that the drug is indicated for approximately 300,000 adults in the United States. The approval follows similar recent approvals of the drug in Europe and China.
Sanofi CEO Paul Hudson said in the news release that the approval brings a new option for patients with type 2 inflammation.
“With [the] approval, Dupixent 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,” he said.
The FDA approval is based on data from two phase 3 studies, BOREAS and NOTUS. The studies evaluated the efficacy and safety of Dupixent compared to placebo in adults who were currently on the maximum standard-of-care inhaled therapy. In most cases, that meant triple therapy.
The studies found that Dupixent produced significant results, including:
- A 30% (BOREAS) and 34% (NOTUS) reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks, the primary endpoint.
- Numerically greater improvements of 74mL and 69mL in post-bronchodilator FEV1 from baseline at week 12 compared to placebo, sustained at 52 weeks.
- 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 the St. George’s Respiratory Questionnaire.
