The blockbuster Sanofi and Regeneron Pharmaceuticals drug Dupixent, already commercialized in several skin and lung disorders, has expanded its FDA-approval to chronic obstructive pulmonary disease (COPD), a progressive lung condition prevalent in smokers.
The regulatory decision announced Friday permits Dupixent’s use as an add-on maintenance treatment of adults whose COPD is inadequately controlled by available therapies. The every-other-week injectable drug is now the first biologic therapy approved by the FDA for treating COPD.
In COPD, damage to the lungs leads to inflamed airways that cause breathing difficulty, coughing, and wheezing. The disease can be caused by long-term exposure to inhaled irritants, which is why it’s prevalent in smokers. But non-smokers can also develop COPD. Standard treatment includes drugs and drug combinations that widen airways and reduce inflammation.
Dupixent is an antibody designed to block IL-13 and IL-4, two signaling pathways that drive inflammation. In COPD, the drug is intended to specifically address type 2 inflammation, an excessive immune response characterized by accumulation of certain immune cells in tissue. Dupixent’s FDA approval in COPD covers the drug’s use to treat patients whose disease is driven by immune cells called eosinophils.
The FDA approval in COPD is based on results from two Phase 3 tests that compared the drug to a placebo in adults who were currently receiving standard-of-care inhaled therapy. Results for both studies showed statistically significant reductions in the annualized rate of moderate or severe COPD exacerbations measured over one year.
Dupixent has been developed under a partnership between Sanofi and Regeneron, who share in profits from the drug. Sanofi recognizes all revenue from antibodies in the partnership. The drug accounted for €10.7 billion (about $11.6 billion) in sales in 2023, up nearly 30% from the prior year, according to the pharma giant’s annual report. Dupixent gives Sanofi a pipeline in a product opportunity, Paul Rowe, Sanofi’s head of medical affairs specialty care North America, said in an interview ahead of the FDA decision. The drug was first approved in 2017 for treating for atopic dermatitis followed by asthma in 2018. With the latest FDA nod, the drug can now treat six respiratory and dermatological conditions.
“Given success we’ve had in these other disorders, we think there’s a strong rationale for COPD as well,” Rowe said.
COPD treatment has mainly consisted of older drugs, mostly inhaled therapies, but that’s changing. In June, the FDA approved Verona Pharma’s Ohtuvayre, an inhalable drug that hits two targets, one to counteract inflammation and the other to open up airways. Dupixent could also face new biologic competition. Nucala, a GSK antibody that blocks the IL-5 pathway, recently posted positive Phase 3 data in a COPD study. The results could represent a comeback for Nucala, which the FDA rejected for COPD in 2018. The injectable GSK drug is currently approved for treating asthma.
An FDA decision for Dupixent in COPD was initially expected in June. But in May, the agency notified the company it needed more time to review additional clinical data it had requested. In a separate Friday decision, regulators in China approved Dupixent for COPD, Sanofi and Regeneron said. Dupixent’s first approval in COPD was in Europe, a regulatory decision handed out in July.
Photo: Nathan Laine/Bloomberg, via Getty Images
