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.
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