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Just a few days after a stumble, FDA OKs 12-week dose for Eylea as Regeneron braces for Novartis attack

Well that didn’t take long.

In perhaps the shortest turnaround from an FDA rejection to an approval, Regeneron says the FDA has flagged their approval to start marketing a new, once-every-12-week dose of Eylea for wet, ager-related macular degeneration. Word of the rejection notice arrived on Monday — noting an issue with labeling discussions — with the news of the green light landing Friday morning.

The approval gives Regeneron $REGN a distinct advantage in the looming showdown it expects with Novartis’ RTH258 $NVS, which has been making slow progress after the pharma giant eagerly announced positive pivotal data for their long-acting approach to macular degeneration. That was seen as a direct threat by the top team at Regeneron, who don’t take any threats lying down.

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.

Some of those analysts were warning investors earlier this week that a tie-up on labeling could translate into a major obstacle for Regeneron. But that was clearly not the case.

Now you can expect some careful analysis of where Regeneron is positioned as it waits for the arrival of RTH258.

Novartis has made no secret of the blockbuster dreams it has for their rival therapy. Vas Narasimhan held RTH258 up as one of the pharma giant’s 4 big late-stage drugs last year, before he was named CEO. But the filing isn’t expected until the fourth quarter, a year after Novartis spelled out positive last-stage data. That would push back any potential showdown with Regeneron until well into 2019, giving Regeneron a key advantage in getting out ahead.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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