Keryx anemia med Auryxia trounces placebo in study aimed at big new use

Right now, Keryx Biopharmaceuticals' ($KERX) Auryxia (ferric citrate) boasts a single indication. But armed with positive new study data, the Boston company is hoping it can soon make it two.

Tuesday, the drugmaker announced that the med had dramatically outperformed placebo when it came to treating iron deficiency anemia in adult patients with non-dialysis-dependent chronic kidney disease. More than half of the 117 patients in the ferric citrate arm (52%) saw their hemoglobin rise past 1 g/dL, while just 19% of those in the placebo group achieved the same result.

It's a win for Keryx, which hopes a label expansion can help it pad last year's $1.01 million in sales. According to CEO Greg Madison, the company's eligible patient population could double with a new FDA nod; 650,000 eligible, predialysis patients are already being seen and treated by the kidney doctors Keryx's 95 reps are now targeting, he told FiercePharmaMarketing in an interview.

"We have a tremendous amount of leverage here with our existing sales force," he said. "The infrastructure we have in place should be more than sufficient to go after this market opportunity."

And once it does, Keryx thinks ferric citrate has some distinct advantages over the currently available treatments that will lead to patient-switching. Right now, the options for patients Keryx hopes to target "are fairly limited," company CMO John Neylan told FiercePharmaMarketing. Existing oral iron supplements "are not well tolerated and poorly effective," he said, while the other option--injectable iron--carries risks for serious side-effects such as anaphylaxis.

Having a new treatment "that is consistent and robust in terms of addressing the need and demonstrating a really profound effect in the magnitude of hemoglobin rise … is really going to be very exciting," Neylan said.

Either way, it shouldn't be too long until Keryx gets the chance to square off against the current options in the marketplace, the company figures. It intends to submit its application for a label expansion to the FDA in the third quarter of this year, and it's raring to go--assuming it snags a green light from the FDA.

"We have the team in … and Keryx Biopharmaceuticals will certainly be ready to take advantage of an indication," Madison said.

- read the release