also, AMAG's decision is coming up - what are their chances here?
i personally don't think they're going to get approved anytime soon, like like SVNT and puricase. i think the fDA is too risk averse right now. but at least they didn't ask amag to run an additional trial.
thoughts appreciated.
17:54 Decision on AMAG's ferumoxytol could come as soon as next month after manufacturing, clinical questions are addressed - executives
Story * Data shows safety advantage even over oral iron
* Drug could interfere with emergency MRIs, one physician suggested
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AMAG Pharmaceuticals is anticipating approval as soon as next month for its high dose, rapid infusion iron replacement product ferumoxytol, according to insiders at the company.
The drug, which is being studied for anemia associated with chronic kidney disease, received a complete response letter from the FDA on 20 October. A spokesperson noted that the agency's concerns relate to manufacturing processes as well as clinical questions.
Yet the company does not need to conduct additional trials and expects the agency to issue a decision within two to six months of its complete response, according to an executive.
The company is prepared to launch the product in 1Q09 and has already hired 80 drug representatives, the spokesperson said, adding that AMAG is not looking for a partner in the US and believes it can target the 4,700 dialysis centers here with its own sales team.
At the meeting of the American Society of Nephrology, investigators reiterated that the product is safe and has convenience benefits.
Dr Brigitte Schiller, a nephrologist and clinical medical director at Satellite Healthcare, noted that dialysis patients typically require two grams of iron - which could mean at least 10 infusions with Watson's InFed or Ferrlecit or American Regent's Venofer or Dexferrum. The maximum dose with each of these products is about 200mg, she said, and each infusion can take up to 15 minutes.
Ferumoxytol, in contrast, delivers 510mg of iron in about a minute. Patients receive two infusions during a one-week period.
Schiller noted that there were no safety signals in the any of the trials, which compared ferumoxytol to oral iron. "Oral iron is a very safe drug," she said. And even still, "when we compare it to the oral iron, the oral iron is actually looking worse."
Adverse events such as diarrhea, nausea, edema, vomiting and constipation were more common in the oral iron group, according to a poster presentation for which Schiller was an investigator. Hypotension was the only adverse event that occurred more frequently in the ferumoxytol group (2.1% compared to 0.3%).
Dr Louis Brenner, senior vice president at AMAG, noted that comparing the drug to oral iron sets a higher safety bar than comparing it to IV iron, which is known to cause anaphylactic reactions. "The threshold for a new product is safety," he said. While he acknowledged that using IV iron would have set a higher bar for efficacy, "the efficacy story with oral iron is fairly well told and it’s more about safety," he said, adding that oral iron is the standard of care outside the dialysis population.
Ferumoxytol is also being studied for additional indications, including other causes of anemia as well as a magnetic resonance imaging agent. One nephrologist in private practice questioned whether using ferumoxytol for iron replacement would interfere with a patient's ability to undergo MRI - and said that he would hesitate to limit diagnostic options for patients.
In an interview, Brenner conceded that its magnetic properties could be a concern for emergency MRIs, but noted that most MRIs are planned. He added that ferumoxytol only has a 15-hour half-life and then "most of it is gone."
Schiller agreed. "I don't think it’s magnetic enough to influence MRIs."
This news service previously reported that IV iron has seen increased use as safety questions have dogged erythropoiesis-stimulating agents (ESAs), the standard of care for anemia in both nephrology and oncology. Many physicians believe that adding iron to ESAs can help lower ESA doses and increase ESA responsiveness.
ESAs include Amgen's Aranesp and Epogen and Johnson & Johnson's Procrit.
AMAG has a market cap of USD 440m.
by Beth Herskovits in Philadelphia
Source Pharmawire
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