The FDA wants more info on Regeneron and Sanofi’s blockbuster Dupixent before it decides whether to approve the treatment for some patients with chronic obstructive pulmonary disease, or COPD.
That request could delay a decision by three months.
Earlier this week, the agency requested more efficacy analyses on subpopulations from two Phase 3 trials submitted as part of the application package, Regeneron CEO Leonard Schleifer said Thursday on the company’s quarterly earnings call.
He said the company plans to provide the data “substantially sooner” than the FDA’s deadline for more information at the end of May. If the FDA needs more time to review the new analyses, the agency could delay its decision beyond the current deadline of June 27. The treatment is also under review in the European Union and Japan for patients with uncontrolled COPD and evidence of type 2 inflammation.
A delay would “hurt the stock — unless there’s a chance it means a broader label,” Cantor Fitzgerald analysts told investors on Thursday.
An expansion into COPD would mark a landmark moment for Dupixent, which has been approved for five indications in the US since 2017 and is used by 850,000 patients globally. Sales jumped 24% to $3.08 billion in the first quarter.
Despite the FDA’s request for additional analyses, Regeneron and Sanofi remain confident in an approval. The agency is reviewing two Phase 3 trials of the biologic, which was tested in COPD patients with high levels of eosinophils. Both studies, which read out last year, showed Dupixent succeeded at reducing flare-ups.
“From our perspective, we think the data broadly supports the entire BLA,” Schleifer said during the call.
If greenlit, Dupixent would be the first biologic for patients with COPD, and the “first new treatment approach” for the disease in more than 10 years, Regeneron said in February.
“As you might imagine, 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 subpopulation of the study that might be driving the data,” Schleifer said. “If one saw that, one might think about labeling it differently, but none of that has occurred.”
“We’ve looked at all these analyses,” he continued. “We’re going to submit them way ahead of the schedule that they’ve asked for, and all of the analyses show a consistent and clinically meaningful reduction in the COPD exacerbations across all of these subgroups that have been asked for.”