FDA approves Genzyme's Renvela for dialysis patients.Genzyme Corporation, Cambridge, MA, announced the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. has granted marketing approval for Renvela for the control of serum phosphorus phosphorus (fŏs`fərəs) [Gr.,=light-bearing], nonmetallic chemical element; symbol P; at. no. 15; at. wt. 30.97376; m.p. 44.1°C;; b.p. about 280°C;; sp. gr. 1.82 at 20°C;; valence −3, +3, or +5. in patients with chronic kidney disease Chronic kidney disease (CKD), also know as chronic renal disease, is a progressive loss of renal function over a period of months or years through five stages. Each stage is a progression through an abnormally low and progressively worse glomerular filtration rate, which is on dialysis. Renvela is a next-generation version of the company's Renagel, the most-prescribed phosphate binder in the US. The company says like Renagel, Renvela is a calcium-free, non-absorbed phosphate binder and will initially be available as 800mg tablets. Renvela offers the benefits of Renagel but has the added benefit of a carbonate buffer. Genzyme says a clinical study comparing the two drugs found both controlled serum phosphorus equally within KDOQI KDOQI Kidney Disease Outcomes Quality Initiative (National Kidney Foundation) recommended ranges. However, patients on Renvela were more likely to maintain bicarbonate bicarbonate or hydrogen carbonate, chemical compound containing the bicarbonate radical, -HCO3. The most familiar of such compounds is sodium bicarbonate (baking soda). See carbonate. levels within the recommended KDOQI ranges and had a lower incidence of gastrointestinal adverse events. Genzyme expects to launch Renvela for dialysis patients in the US during the first quarter of 2008, and is pursuing regulatory approvals in Europe, South American and in other international markets. Renagel will continue to be available but the long term goal is to transition all patients to Renvela. Contact: Web site - www.genzyme.com or www.renvela.com |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion