A highly anticipated decision on Sanofi and Regeneron’s Dupixent to become the first biologic to treat chronic obstructive pulmonary disorder (COPD) is on hold in the United States but is speeding along in Europe.
Five minutes apart on Friday morning, the companies reported good and bad news from regulators on their applications for Dupixent to treat COPD. In the U.S., the FDA has pushed its planned decision date back three months to Sept. 27. Meanwhile in Europe, the Committee for Medicinal Products for Human Use (CHMP) has recommended Dupixent for approval to treat the disease, which is the world’s fourth-leading cause of death.
The FDA delay was not a surprise. Early this month, in presenting its first-quarter results, Regeneron revealed that the U.S. regulator had requested additional data from two trials that have set Dupixent up for the potential label expansion.
“Based on the submission of these analyses earlier in May, the agency has now determined that this additional information constituted a major amendment to the (supplemental biologics license application) and extended the target action date accordingly,” Regeneron said in a release.
Four weeks ago, Regeneron CEO Len Schleifer said that the FDA wanted to see sub-population breakdowns from the phase 3 BOREAS and NOTUS trials.
“Our analyses across these requested patient subgroups indicate a consistent and clinically meaningful reduction in COPD exacerbations,” Schleifer said at the time. “The FDA, when anticipating or looking at a new class of biologics, is very interested in checking it up and down, and down and up, and making sure that there’s no sub-population of the study that might be driving the data.”
On Friday, Regeneron added that the companies “are confident that the additional analyses strongly support the approval.”
The delay could give Verona Pharmaceuticals a head start in its bid to treat COPD with its first-in-class drug ensifentrine—a dual action inhibitor of the phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes.
The FDA decision date for ensifentrine is June 26. The company said this month that it expects to launch the in the third quarter of this year. GlobalData has called ensifentrine a “paradigm shift” in the indication and projected it to become a blockbuster by 2029.
In recommending Dupixent for approval in what would be its seventh indication, the CHMP cited results from the NOTUS and BOREAS trials. In those studies, Dupixent reduced exacerbations from COPD by 34% and 30% versus placebo, respectively.
Two months ago, analysts at Evercore ISI projected that a COPD nod would add a potential sales boost of $3.5 billion annually for Dupixent, bringing its peak sales potential to $20 billion.