Genzyme's Renvela receives positive opinion in EU for hyperphosphataemia
This article was originally published in Scrip
The EU's CHMP has issued a positive opinion for Genzyme's Renvela (sevelamer carbonate) 800mg tablet, and 1.6 and 2.4g powder for oral suspension, for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Renvela is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus >1.78 mmol/l.
Renvela is a next-generation version of Genzyme's Renegal (sevelamer hydrochloride).While both are a calcium-free, metal-free, non-adsorbed phosphate binder, Renvela is also a carbonate buffer.
The committee notes that Renvela contains multiple amines separated by one carbon from the polymer backbone. These amines become partially protonated in the intestine and interact with phosphate ions through ionic and hydrogen bonding. By binding phosphate in the gastrointestinal tract, sevelamer lowers the phosphate concentration in the serum. Sevelamer decreases the incidence of hypercalcaemic episodes as compared to patients using calcium based phosphate binders alone, probably because the product itself does not contain calcium.
The CHMP also notes that Renvela should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Elevated serum phosphorus levels are common in patients with chronic kidney disease because phosphorus is not easily filtered by the disease-impaired kidneys and therefore accumulates in the body. This can lead to calcification of tissues, and increased risk of cardiovascular mortality.
According to the company, while both products control serum phosphorus equally to within recommended ranges, patients treated with the newer product are more likely to maintain bicarbonate within recommended ranges and have a lower incidence of GI side-effects (scripnews.com, March 12th, 2008).
Renvela was first launched in the US in 2008 for the control of hyperphosphataemia in adult patients with kidney disease on dialysis. The company is also seeking FDA approvals of the powder formulation and for the treatment of hyperphosphatemic chronic kidney disease patients not receiving dialysis.