Sanofi and Regeneron's Dupixent Wins FDA Approval for COPD

Sanofi and Regeneron Pharmaceuticals have achieved a significant milestone with their drug, Dupixent. Already a prominent medication for various skin and lung diseases, Dupixent has now received FDA approval for treating chronic obstructive pulmonary disease (COPD), a progressive lung condition commonly associated with smokers. This approval marks a pivotal moment as Dupixent becomes the first biologic therapy sanctioned by the FDA for COPD.

COPD, a condition characterized by lung damage leading to inflamed airways, causes symptoms such as breathing difficulty, coughing, and wheezing. While typically linked to long-term exposure to inhaled irritants like cigarette smoke, non-smokers can also develop the disease. Standard treatments have primarily involved drugs and combinations that help widen airways and reduce inflammation.

Dupixent works as an antibody targeting two inflammatory pathways, IL-13 and IL-4. In the context of COPD, it specifically addresses type 2 inflammation, which is marked by an abnormal immune response with the accumulation of immune cells in the lung tissue. The FDA’s approval covers the use of Dupixent in treating COPD patients whose condition is driven by immune cells known as eosinophils.

The FDA's decision was influenced by results from two Phase 3 clinical trials, which compared Dupixent to a placebo in adults already on standard inhaled therapies. Both studies demonstrated significant reductions in the rate of moderate or severe COPD exacerbations over a year.

Sanofi and Regeneron have jointly developed Dupixent and share the profits from this drug. Sanofi, responsible for the revenue from these sales, reported that Dupixent generated approximately €10.7 billion (around $11.6 billion) in sales for 2023, reflecting a nearly 30% increase from the previous year. The drug, initially approved in 2017 for atopic dermatitis and later for asthma in 2018, now addresses six different respiratory and dermatological conditions with its most recent FDA approval for COPD.

Paul Rowe, Sanofi’s head of medical affairs specialty care for North America, expressed confidence in Dupixent’s potential to treat COPD, citing the drug's success in other disorders. He emphasized the strong rationale for its efficacy in COPD, given its performance in previous applications.

The landscape of COPD treatment traditionally relied on older, mostly inhaled therapies. However, advancements are being made. For example, in June, the FDA approved Verona Pharma’s Ohtuvayre, an inhalable drug targeting both inflammation and airway obstruction. Additionally, Dupixent might soon face competition from other biologics; GSK's Nucala, an antibody targeting the IL-5 pathway, showed promising Phase 3 results in a recent COPD study after initially being rejected by the FDA for COPD in 2018.

While the FDA’s decision for Dupixent in COPD was anticipated in June, additional clinical data requests delayed the final approval. Alongside the FDA approval, regulators in China also approved Dupixent for COPD, following its first approval in Europe in July.

Overall, the FDA’s approval of Dupixent for COPD signifies a major advancement in the treatment options available for this chronic lung disease. With this development, patients have access to a new, biologic therapy designed to address inflammation at its source, potentially improving outcomes for those suffering from this debilitating condition.

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