Sanofi-Regeneron's Dupixent COPD Bid: Europe Positive, US Negative

Sanofi and Regeneron are encountering mixed responses from regulatory bodies regarding their application for Dupixent to treat chronic obstructive pulmonary disorder (COPD). While progress is being made in Europe, the situation in the United States is more complex.

On a recent Friday morning, the companies announced both positive and negative updates on their applications for Dupixent concerning COPD. In the United States, the Food and Drug Administration (FDA) has postponed its decision by three months, shifting the target date to September 27. Contrarily, in Europe, the Committee for Medicinal Products for Human Use (CHMP) has recommended approving Dupixent for treating COPD. This condition is the fourth leading cause of death globally.

The FDA’s delay was somewhat anticipated. Earlier in the month, Regeneron disclosed during its first-quarter results presentation that the U.S. regulator had requested additional data from two trials that are crucial for the potential expansion of Dupixent's approved uses. According to Regeneron, the submission of these analyses earlier in May led the FDA to determine that this new information amounted to a major amendment to the supplemental biologics license application, thus extending the decision date.

Regeneron CEO Len Schleifer had revealed four weeks prior that the FDA requested a detailed breakdown of sub-populations from the phase 3 BOREAS and NOTUS trials. Schleifer emphasized that the analyses across these subgroups show a consistent and clinically significant reduction in COPD exacerbations. He mentioned that the FDA is meticulously examining the data since it involves a new class of biologics, ensuring no specific subgroup is skewing the results.

Regeneron expressed confidence that the additional analyses robustly support the approval. However, this delay might provide Verona Pharmaceuticals an edge in its endeavor to introduce its drug ensifentrine for COPD treatment. Ensifentrine is a dual-action inhibitor of the phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes, and its FDA decision date is set for June 26. Verona Pharmaceuticals anticipates launching the drug in the third quarter of this year. GlobalData has described ensifentrine as a “paradigm shift” for the indication, expecting it to achieve blockbuster status by 2029.

The CHMP’s recommendation for Dupixent’s approval, which would mark its seventh indication, was based on the outcomes of the NOTUS and BOREAS trials. These studies demonstrated that Dupixent reduced COPD exacerbations by 34% and 30% compared to a placebo, respectively.

Two months ago, analysts at Evercore ISI projected that gaining approval for COPD could potentially boost Dupixent’s sales by $3.5 billion annually, raising its peak sales potential to $20 billion.

In summary, while Sanofi and Regeneron face a delay in the U.S., their push for Dupixent to treat COPD is progressing in Europe, with significant implications for the future market landscape and potential sales growth.