Genzyme Corp. announced that the US Food and Drug Administration have granted marketing approval for Renvela (sevelamer carbonate) for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Renvela is a next-generation version of Renagel (sevelamer hydrochloride), the most-prescribed phosphate binder in the United States.
"Since its approval in 1998, Renagel has made an important difference for hundreds of thousands of patients around the world. The present approval of Renvela - an improved form of Renagel - is a key milestone in our ongoing effort to innovate on behalf of patients. As we prepare to launch Renvela for patients on dialysis, we will move forward with regulatory filings to gain approval for the product's use in earlier stages of chronic kidney disease, so that all patients who can benefit from this treatment have access to it," said John P. Butler, president, Genzyme Renal. "
Like Renagel, Renvela is a calcium-free, metal-free, non-absorbed phosphate binder and will initially be available as 800mg tablets. Renvela offers all of the advantages of Renagel with the added benefit of a carbonate buffer. In a clinical study comparing Renvela to Renagel, both drugs controlled serum phosphorus equally to within KDOQI recommended ranges. Patients on Renvela, however, were more likely to maintain bicarbonate 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 United States during the first quarter of next year, and is pursuing regulatory approvals in Europe, South America and in other markets internationally. The company will continue to make Renagel available, with the long-term goal of transitioning patients to Renvela.
"Renvela's approval represents an important advance for chronic kidney disease patients. It is an improved version of a well-established product that has been shown to provide significant advantages to patients," said Craig Langman, M.D., the Isaac A. Abt M.D. professor of kidney diseases, Feinberg School of Medicine, Northwestern University.
During the first half of next year, Genzyme also plans to file a supplemental New Drug Application with the FDA seeking approval of Renvela for hyperphosphatemic patients with chronic kidney disease who are not on dialysis. In addition, Genzyme expects to file for approval of a powder form of Renvela that may make it easier for patients to comply with their prescribed treatment programme.
The FDA also recently approved a label extension for Renagel for the control of serum phosphorus for patients on peritoneal dialysis. The treatment had previously been approved in the US only for patients on hemodialysis. The Renvela approval announced today includes patients on both types of dialysis.
Renagel (sevelamer hydrochloride) and Renvela (sevelamer carbonate) both control serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Controlling serum phosphorus is an important element in the care of dialysis patients. Elevated serum phosphorus levels are common in dialysis patients and associated with increased risk of cardiovascular morbidity and mortality. Sevelamer provides the added benefit of significant LDL cholesterol reduction.
Sevelamer is the only phosphate binder available that does not contain either calcium or a metal. It has an established safety profile, is not systemically absorbed and provides phosphorus control without the concerns of calcium or metal accumulation. The National Kidney Foundation's 2003 Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines for Bone Metabolism and Disease in CKD recommend sevelamer as a first-line treatment option to control phosphorus. Sevelamer hydrochloride is currently used by more than 350,000 patients worldwide.
Renvela is indicated for the control of serum phosphorus in patients with CKD on dialysis. It is contraindicated in patients with hypophosphatemia or bowel obstruction. Caution should be exercised in patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation, or major GI tract surgery. The most common adverse events included vomiting, nausea, diarrhoea, and dyspepsia, the company informed
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with nearly 10,000 employees in locations spanning the globe and 2006 revenues of $3.2 billion.