Genzyme Corp. Files NDA on Treatment for Dialysis Patients.
Genzyme Corp. has filed a New Drug Application with the U.S. Food and Drug Administration to seek approval of sevelamer carbonate for the control of serum phosphorus in patients with chronic kidney disease on dialysis.
Sevelamer carbonate will be marketed under the trade name Renvela.
Renvela is being developed as a next generation phosphate binder to replace Renagel (sevelamer hydrochloride), the most-prescribed phosphate binder in the United States. Genzyme is seeking approval for use of Renvela in patients with chronic kidney disease (CKD) on dialysis. Like Renagel, Renvela is a non-calcium, non-metal, non-absorbed phosphate binder and will be available in 800mg tablets.
"Submission of this NDA marks an important milestone as we prepare to introduce our next generation of sevelamer," said John P. Butler, president, Genzyme Renal. "Development of this therapy demonstrates our commitment to meeting the needs of all patients who can benefit from using sevelamer."
In addition to today's filing, Genzyme said it is advancing a clinical program investigating the use of Renvela for hyperphosphatemic patients with chronic kidney disease who have not progressed to dialysis. Enrollment has been completed in the study evaluating Renvela for this indication.
Enrollment is also complete in a study comparing a powder form of sevelamer carbonate dosed once a day to Renagel tablets dosed three times a day. Development of a powder form of the product would offer a more convenient option for patients, thereby improving compliance, Genzyme said.
For more information, visit www.renagel.com.
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((Distributed via M2 Communications Ltd - http://www.m2.com))
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|Date:||Dec 21, 2006|
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