Latebreakers: Renvela OK'd for CKD patients on dialysis

November 5, 2007

FDA approves new form of sevelamer for chronic kidney disease

The FDA has approved a new form of sevelamer, a phosphatebinder used to treat patients with chronic kidney disease (CKD) who are on dialysis. Renvela (sevelamer carbonate) differs from its predecessor Renagel (sevelamer HCl) in that it offers the added benefit of a carbonate buffer, according to manufacturer Genzyme Corp. Both products are calciumfree and are not systemically absorbed; however, in clinical trials comparing the two agents, Renvela (see http://www.renvela.com/) was more likely to maintain bicarbonate levels within the recommended National Kidney Foundation's Kidney Disease Outcomes Quality Initiative, or KDOQI, ranges in addition to controlling serum phosphorus levels. It also had a lower incidence of GI adverse effects. Genzyme expects to launch Renvela during the first quarter of 2008 in 800-mg tablets.