Genzyme moves ahead with powder form of sevelamer carbonate after good trial results

Published: 19-Jun-2007
Regulatory

Genzyme Corp has released to results of two new studies comparing a powder form of Renvel (sevelamer carbonate) to Renagel tablets (sevelamer hydrochloride), including one trial in which patients received the powder form three times per day, and one in which it was administered once per day.


Genzyme Corp has released to results of two new studies comparing a powder form of Renvel (sevelamer carbonate) to Renagel tablets (sevelamer hydrochloride), including one trial in which patients received the powder form three times per day, and one in which it was administered once per day.

Renvela is a buffered form of Renagel, the most-prescribed phosphate binder in the US. Like Renagel, Renvela is a calcium-free, metal-free, non-absorbed phosphate binder, and will be available as 800mg tablets once approved.

Genzyme has been developing Renvela in powder form to provide an additional option for patients with chronic kidney disease in managing their phosphate levels. A New Drug Application for Renvela tablets is already on file with the FDA.

The company has concluded from the latest results that the powder formulation of Renvela dosed three times per day may represent a promising alternative for patients with chronic kidney disease. The company will continue to move ahead aggressively with clinical and regulatory plans for the powder formulation dosed three times per day, and these data will form part of an NDA submission in the first half of 2008.

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