Regeneron hopes for quick FDA decision on high-dose Eylea as Roche's rival surges

In a high-stakes race of their eye disease drugs, Roche has sprinted to a significant lead over Regeneron. Last week, the Swiss pharma giant revealed that its anti-VEGF treatment Vabysmo had crossed the blockbuster threshold.

Much of the drug’s $1.1 billion revenue in the first half of 2023 came at the expense of Regeneron, which has developed a high-dose version of its Eylea (aflibercept) as a countermeasure but has yet to get it approved.

On Thursday, as it reported its second quarter earnings, Regeneron said that the company is hoping for a third-quarter decision from the FDA and a chance to play catch up after a surprise rejection in June.

With the news, Regeneron’s shares had risen by 5% by mid-morning on Thursday.

Regeneron’s hope to launch 8 mg Eylea was delayed in June when the FDA rejected it because of a manufacturing issue. On Thursday, Regeneron said that its third-party manufacturer Catalent will submit information to the FDA in the middle of this month that could clear the way for an approval.

A filler problem at Catalent’s massive plant in Bloomington, Indiana, was cited in the FDA’s complete response letter (CRL). A May inspection of the facility led to three observations in a Form 483 citation.

“We, Catalent and the FDA have had multiple discussions since the aflibercept 8 mg CRL,” Regeneron CEO Len Schleifer said in a conference call. “There is a clear understanding of the remediation work that is required to allow the FDA to resume approving BLAs that involve manufacturing on this line.”

The FDA has told Regeneron that it will complete its review “expeditiously,” Schleifer added.

Along with the submission for high-dose Eylea, the FDA is considering an application for Regeneron’s Chaple disease drug pozelimab, which has an August 20 target action date. Catalent’s filler issue also needs to be resolved before the decision on pozelimab can be executed.

If the FDA can’t complete its review by August 20, it has told Regeneron that it may extend the evaluation by up to three months. Even if this happens, Regeneron expects the review to take place by the end of September, given the regulator’s pledge to expedite the review.

Whenever Eylea is approved, an interesting battle will ensue. While studies indicate that high-dose Eylea has superior staying power to that of Vabysmo, Roche counters that its treatment dries the retina more effectively.

When asked about Roche’s claim on Thursday, Regeneron dodged the question, with commercializtion head Marion McCourt saying that the company still sees Eylea as the potential standard of care in the category.

Meanwhile, as Vabysmo sales continue to surge, Eylea’s remain stagnant. Regeneron reported $1.5 billion in sales in the United States from Eylea, a 7% drop from the second quarter of last year and matching the figure from the first quarter of this year.

Eylea’s U.S. sales peaked in the second quarter of 2022 at $1.63 billion before eroding amid growing competition from Vabysmo, which was approved in January of 2022.

Helping overcome the stagnant sales of Eylea was Regeneron’s other blockbuster, Sanofi-partnered Dupixent, which generated worldwide sales of $2.8 billion in the quarter. It was a 33% increase year over year.

The performance of Dupixent and cancer drug Libtayo—which saw a 49% year-on-year increase in sales to $210 million for the quarter—allowed Regeneron to reach revenue of $3.16 billion for the quarter. The haul topped Zacks Investment Research's projection of $3.01 billion and matched Regeneron's sales figure for the first quarter. It was an 11% gain from the second quarter of last year.