Sanofi and Regeneron's Dupixent Receives Final Approval from EMA for COPD Treatment in Europe
A Groundbreaking Biologic Set to Transform the COPD Market
The European Medicines Agency (EMA) has granted final approval for Dupixent (dupilumab) from Sanofi and Regeneron Pharmaceuticals for the treatment of chronic obstructive pulmonary disease (COPD). This approval targets adult COPD patients with Type 2 inflammation who are not adequately controlled with existing inhaled therapies. Dupixent selectively inhibits the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), key drivers of Type 2 inflammation, by targeting the IL-4 receptor alpha (IL-4Rα). COPD treatment has historically been limited to symptom-relieving inhaled medications; this approval marks the arrival of the first biologic that addresses the underlying inflammatory cause of the disease.
Demonstrated Superior Efficacy in the BOREAS and NOTUS Phase 3 Trials
The regulatory approval is based on the BOREAS and NOTUS Phase 3 clinical trials. These trials involved patients with elevated Type 2 inflammation levels (blood eosinophil counts of 300 cells/μL or higher). The trials demonstrated that Dupixent reduced the annualized rate of COPD exacerbations by 30% and 34%, respectively, compared to placebo. Furthermore, the drug significantly improved lung function (FEV1) at 12 weeks compared to the placebo group, and this effect was sustained for 52 weeks, showcasing its remarkable clinical efficacy. This compelling data played a crucial role in the EMA's swift approval decision.
Commercial Success Exceeding 15 Billion Euros Annually and Significant Financial Value
The commercial success of Dupixent continues to strengthen the financial position of Sanofi and Regeneron. In 2024, global sales of Dupixent reached 13 billion euros (approximately $14.1 billion), and in 2025, it is projected to reach 15.7 billion euros (approximately $17.8 billion), representing a 25.2% increase year-over-year. According to the agreement between the two companies, profits in the United States are split 50/50, while outside the United States, Sanofi receives 55% to 65% of the sales. This European approval for COPD is expected to further accelerate Dupixent's peak sales, potentially exceeding 20 billion dollars.
Intensifying Competition in the Immunological Disease Market and Securing a Leading Position
With approximately 300 million COPD patients worldwide, and a significant portion of them having Type 2 inflammation, the market potential is immense. While AstraZeneca's Tezspire and GlaxoSmithKline's Nucala are competing in the COPD space, Dupixent's first-mover advantage is substantial. As the first biologic for COPD, the real-world data it accumulates will create a significant barrier to entry for competitors. This approval signals a shift in the standard of care for respiratory diseases in the European market.
This European approval of Dupixent for COPD represents a historic turning point, marking the entry of the first biologic into the global COPD market, which comprises 300 million patients. The 30-34% reduction in exacerbation rates demonstrated in the BOREAS and NOTUS Phase 3 trials provides a strong benchmark against competitors such as AstraZeneca's Tezspire, widening the technological gap. In the short term, it will accelerate the growth of global sales, which reached 15.7 billion euros in 2025, and boost earnings forecasts for Sanofi and Regeneron, given the revenue-sharing structure outside the United States (55-65% to Sanofi). In the medium to long term, it is expected to establish a new standard of care for Type 2 eosinophilic COPD patients, significantly accelerating the timeline for achieving peak annual sales of 20 billion dollars. Furthermore, the successful expansion of biologics into COPD indications provides a new target discovery strategy for the broader biotech ecosystem focused on immuno-oncology and inflammatory diseases.
Source: EMA (ema)