Regeneron flags possible DupixentDupixent COPD decision delay after FDA data request

02 May 2024
firstwordpharma.com
Priority Review
Alongside its first-quarter results presentation on Thursday, Regeneron Pharmaceuticals hinted that a key label expansion for its Sanofi-partnered autoimmune drug Dupixent in chronic obstructive pulmonary disease (COPD) could be delayed by three months after the FDA asked to see more data.
The application is currently under a priority review with a target action date of June 27. But on a call with analysts Thursday, CEO Leonard Schleifer said the US regulator has asked to see additional efficacy analyses, including an information request received earlier this week on subpopulations from the pivotal BOREAS and NOTUS studies.
Decision could be pushed to September
"Our analyses across these requested patient subgroups indicate a consistent and clinically meaningful reduction in COPD exacerbations," said Schleifer, adding that Regeneron thinks it can submit the analyses "substantially sooner" than the end-of-May deadline it has been given.
Although he conceded that a decision on the filing could be pushed back up to three months if the FDA decides it needs more time to conduct its review. Sanofi, which reports Dupixent sales, recently said the drug's revenues grew 22% in the first three months of this year to €2.8 billion, and that it was on track to generate around €13 billion in 2024.
Inventory impacts on Eylea
Elsewhere, Regeneron reported a 2% year-over-year decline in US sales of its blockbuster macular degeneration drug Eylea and new higher-dose formulation, which brought in a combined $1.4 billion in the first quarter. That fell short of the $1.9 billion analysts were projecting.
According to Regeneron, the drop was primarily driven by market dynamics that led to lower volumes and selling price for the drug. Eylea sales were also hit by approximately $40 million in Q1 due to a reduction in inventory held by wholesalers.
Still, the higher 8mg dose of Eylea brought in $200 million, edging past analyst estimates by about $4 million. "We had a strong quarter of Eylea HD uptake, and we are well positioned to continue our leadership in retinal diseases," said Schleifer.
Sales of the regular-dose version of the drug were down 16% to $1.2 billion in the quarter.
While the Eylea franchise faces mounting pressure from Roche's rival treatment Vabysmo, key opinion leaders (KOLs) expect that the higher-dose version's ability to reduce injection frequency could help retain its market dominance.
Meanwhile, Regeneron's total revenues for the quarter slipped 1% year-over-year to $3.1 billion. Excluding sales of the COVID-19 antibody treatment Ronapreve, which saw diminished demand, revenues increased 7%.
Regeneron's cancer drug Libtayo also posted solid growth, with global net sales rising 49% to $264 million, ahead of estimates at $257.7 million.
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