Keryx looks to boost 'disappointing' Auryxia with new iron deficiency launch

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Kidney specialist Keryx this week won its second FDA approval for Auryxia.

Keryx’s Auryxia has so far struggled to get off the ground. But after winning its second FDA approval, the company’s now prepping for a launch that it thinks can take the drug to the next level.

Tuesday, Auryxia nabbed an OK to treat iron deficiency in patients with chronic kidney disease, a condition the company says affects more than half the approximately 30 million chronic kidney disease sufferers in the U.S.

It’s a go-ahead that leverages the same target nephrologists who use Auryxia to treat dialysis patients for hyperphosphatemia—and the same sales force of 95 reps, who have been working for nearly three years to build relationships with those nephrologists, Doug Jermasek, Keryx’s VP of marketing and strategy, told investors on this week’s Q3 earnings call.

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This time around, though, Keryx will be focusing on three key objectives, he said: driving “rapid awareness” of the new indication, differentiating Auryxia from the options already out there and making sure prescribers and patients know about the med’s “favorable insurance access,” with “broad” Medicare Part D access already in place.

When it comes to the middle objective, Keryx has reason to believe that both schools of prescribers—those who reach first for IV iron and those who rely on oral meds—are anticipating Auryxia’s arrival. “The IV iron users find Auryxia's efficacy profile attractive,” while “the oral iron users gravitate to its tolerability and convenience profile,” Jermasek said.

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But that doesn’t mean the Boston-based company’s job will be easy. “We know that we have a lot of hard work ahead of us, primarily focused on changing the way physicians view oral iron,” Jermasek said, noting that, “Over and over in market research we have heard physicians initially express skepticism about whether an oral medicine like Auryxia can work in patients with chronic kidney disease.”

If Keryx can hit its marks, the new indication will expand on the $13.6 million in U.S. sales Auryxia drummed up in Q3. In a note last month to clients, Leerink Partners analyst Seamus Fernandez called the product’s launch “disappointing.”