UK drugmaker Shire will be disappointed by news that itsFosrenol failed to meet the primary endpoint of a Phase II trial of reducingthe amount of phosphate in pre-dialysis patients with stage 3 and 4 chronickidney disease to normal levels.
However, it was not all bad news; the firm pointed out thatmore patients treated with Fosrenol (lanthanum carbonate) achieved this goalthan those in the placebo arm, and the trial did meet its secondary goal of astatistically-significant cut in phosphate levels versus the control,indicating that the agent can effectively reduce serum phosphate levels in CKDpatients not yet receiving dialysis.
First launched in 2005, Fosrenol is already available in 23countries worldwide for the reduction of phosphate levels in patients with endstage (stage 5) renal disease. While hyperphosphataemia is more common at thisstage of the disease, the problem of can start before patients requiredialysis.
Serious health problems
The management of hyperphosphataemia – which occurs as thekidneys lose their ability to excrete phosphate – is crucial for patients withCKD, as excess levels can lead to serious health problems such ascardiovascular disease and brittle bones. In fact, research has shown that foreach mg/dL increase in mean serum phosphorus, the relative risk of deathincreases by 6%, the firm noted.
According to Shire, the findings of the Phase II trial addfurther credence to the recent recommendation of a US Food and DrugAdministration Cardiovascular and Renal Drugs Advisory Committee to extend theuse of phosphate binders to include treatment of CKD stage 4 patients withhyperphosphataemia.
Consequently, the company says it is working closely with USregulators to determine the best regulatory pathway to get patients who wouldbenefit access to Fosrenol at an earlier stage.