Racing Novartis on Eylea rival, the FDA trips up Regeneron at the finish line

An aggressive Regeneron $REGN has run into a roadblock in its quest to get out ahead of a potential Eylea rival from Novartis.

The big biotech, not known for casually ceding market territory to any competitor, says its supplemental BLA for its once-every-12 week dose of Eylea for wet, age-related macular degeneration has been rejected by the FDA.

Facing an August 11 PDUFA deadline, says Regeneron, the FDA kicked out the application “due to ongoing labeling discussions” — and that could indicate a big advantage for its rivals at Novartis.

Regeneron isn’t saying what the sticking points are, but with Novartis’ RTH258 $NVS breathing down its neck, a problem with the label could play a major role in the anticipated showdown between the two companies.

Rather than start over with a new application, Regeneron says it expects to get through label negotiations and get a decision from regulators in a couple of months. A spokesperson for Regeneron explains to me that that is because they are making a Class 1 resubmission, which starts the countdown clock over at 2 months once the added information arrives.

Analysts aren’t going to be happy about even a short interruption here, or an indication that Regeneron may be left in an uncompetitive situation. 

Jefferies’ analyst Biren Amin called the setback a surprise, and noted that the delay could be extended if Regeneron feels a need to go beyond the Phase IV data it had supplied for the sBLA. “We think REGN may bring up the ALTAIR data however that would be considered a major data amendment and require a more signficiant FDA review,” Amin noted.

Eylea’s $5 billion in revenue makes it the productive cash cow that supports the company’s R&D work and co-commercialization pacts with Sanofi on a slate of new, up-and-coming drugs. But the aging franchise has been peaking out, leaving analysts a little dissatisfied with its big earner. New drug sales, though, are on the rise. And Regeneron and Sanofi are also expected to pick up a near-term approval for cemiplimab, the world’s sixth PD-1/L1 drug.

Dirk Sauer

Novartis, meanwhile, has been accelerating its work on the competing drug RTH258, leaning heavily on its 12-week dosing schedule to offer an earlier treatment regimen for patients who understandably may prefer fewer eye injections. 

Novartis knows it will have a fight on its hands, but believes they’re positioned to overcome Regeneron on its home turf.

“I can’t speculate on the FDA label for Eylea or for ours, but the data are not the same,” Dirk Sauer, head of Novartis’ ophthalmology unit, told us a few months ago. “We did a prospective analysis, while they went back and did a retrospective analysis. Retrospective analyses, from an analytical and statistical point of view, are weaker.”

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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