Sanofi and Regeneron’s highly anticipated approval of Dupixent to treat chronic obstructive pulmonary disease (COPD) could be delayed, Regeneron CEO Len Schleifer said on Thursday.
Earlier this week, the FDA requested additional efficacy analyses from two trials that have set Dupixent up for the potential label expansion. In February, the regulator accepted the application and designated it for priority review with a decision date of June 27.
The FDA wants to see sub-population breakdowns from the phase 3 BOREAS and NOTUS trials, Schleifer said during Regeneron’s first-quarter earnings call.
“Our analyses across these requested patient subgroups indicate a consistent and clinically meaningful reduction in COPD exacerbations,” Schleifer said, adding that the companies will provide the information “substantially sooner” than the FDA’s deadline of the end of May.
If the FDA needs more time to review the data, the decision could be delayed for up to three months, the CEO said.
“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,” Schleifer said. “But none of that has occurred [for Dupixent].”
The regulatory hurdle follows one Regeneron endured last year when another of its anxiously awaited products—a high-dose version of blockbuster macular degeneration drug Eylea—was rejected by the FDA because of a manufacturing issue with a third-party drug filler.
Oddly enough, that Eylea priority review carried the same June 27 FDA target decision date a year earlier. Regeneron quickly ironed out the problem, and the FDA endorsement came less than two months later.
At the time, Regeneron and Sanofi were playing catch up with Roche and its new bispecific drug Vabysmo. Ten months later, the partners are still trying to reclaim the market they’ve lost to the Swiss newcomer.
On Thursday, Regeneron reported that U.S. sales of the Eylea franchise were down 2% year-over-year to $1.4 billion, with Eylea HD accounting for $200 million. The performance came up far short of analysts’ consensus of $1.86 billion. There was an uptick sequentially for Eylea HD, as its sales in the previous quarter were $123 million.
Meanwhile, sales of Vabysmo have continued to beat expectations. Last week Roche reported its Vabysmo sales at 847 million Swiss francs ($927 million), which was up 108% year over year and routed the analyst projection of 750 million Swiss francs ($821 million).
Schleifer said that TV promotion, broad prescriber familiarity and satisfaction with the clinical profile will help fuel the uptake of Eylea HD. Another positive is that Eylea HD’s permanent J-code—which streamlines the billing and reimbursement process for Medicare Part B prescriptions—was established on April 1.
Analysts at Leerink Partners also pointed to a $40 million channel inventory reduction in the first quarter. If Eylea HD sales are adjusted to account for the reduction, they would have met their estimate for Eylea HD sales in the period.
“This reflects a sequential draw down of Eylea inventory, which was partially offset by a modest increase in Eylea HD inventory ahead of the permanent J-code on April 1,” Marion McCourt, Regeneron’s chief commercial officer, explained.
Overall for the quarter, Regeneron’s revenue was at $3.14 billion, which is down 1% year over year and came up short of analysts’ expectations of $3.22 billion. There still is a COVID effect however, as excluding sales of antibody treatment Ronapreve, revenue was up 7%.
Compensating for the stagnant sales of Eylea is the continued rise of Dupixent. Sales for the IL-4/13 inhibitor, which are recorded by Sanofi, were up 24% to $3.1 billion. As a result, Regeneron’s collaboration cut from Sanofi rose 14% to $910 million for the period.
Regeneron’s oncology treatment Libtayo continued its rise, fueled by two approvals to treat advanced non-small cell lung cancer. Sales were up 50% to $244 million for the quarter, putting Libtayo on track to become a blockbuster for the first time since it entered the market in 2018.