The US Food and Drug Administration has given Vifor Fresenius Medical Care Renal Pharma an action date of December 1 for its hyperphosphatemia drug PA21.
The Prescription Drug User Fee Act target date from the FDA comes as the company, a venture set up in 2011 by Vifor Pharma's parent company Galenica and Fresenius Medical Care, gears up for launches. Filings for PA21 (iron(III)-oxyhydroxide) have been submitted to the European Medicines Agency and regulators in Switzerland and Singapore.
PA21 is a chewable, iron-based phosphate binder for the control of hyperphosphatemia in patients with chronic kidney disease on dialysis. Phase III data demonstrated that the drug successfully controls the accumulation of phosphorus in the blood with the advantage of a low pill burden - three-to-four versus nine on average per day.
Vifor Fresenius Medical Care Renal Pharma chief executive Charles DeLoach told PharmaTimes World News that for the past 15 months, the company has been working extensively in the USA and in the individual countries of the EU to prepare for launch and has made key appointments in the areas of reimbursement and medical affairs, as well as adding new sales personnel.
Mr DeLoach noted that the firm has been doing market research over the past several months, and cited a case of seven US physicians who, when asked by a moderator, declared "almost unanimously that the biggest problem is that patients are not taking their medications. It's a compliance issue".
He added that the issue of pill burden "is a huge one" but patients also express concerns about side effects and the taste. Mr DeLoach stated that the company, before the venture was set up, "looked at everything, the density of the tablet and the flavour" and tested them with dialysis patients. "We are excited because we believe we do have something whereby physicians will see more of their patients having their phosphorus levels controlled".
Promotion will be carried out by Fresenius Medical Care Renal Pharma, Mr DeLoach said, noting that the latter is well-established and has experience of selling phosphate binders. The latter also owns dialysis clinics Stateside as well as internationally and PA21 will be "a nice addition to their current portfolio".
Other filings are planned for additional European states outside the EU and specific markets in the Middle East, Latin America and Asia-Pacific.