Pursues Additional Approvals Globally for Dialysis and Earlier Stage
Chronic Kidney Disease Patients
CAMBRIDGE, Mass., March 6 /PRNewswire-FirstCall/ -- Genzyme Corp. (Nasdaq: GENZ) today announced the U.S. launch of the phosphate binder Renvela(R) (sevelamer carbonate) for dialysis patients, as well as significant progress in its international efforts to secure additional approvals for the product.
Genzyme has submitted a marketing authorization application to the European Medicines Agency seeking approval of Renvela for the control of serum phosphorus in chronic kidney disease patients regardless of whether they are on dialysis. This application, which includes both tablet and powder formulations, must be validated before it will be accepted for review.
Genzyme anticipates that the application will be validated by the end of this month, and the review period is expected to take approximately 15 months. The first E.U. launch of Renvela is anticipated in the third quarter of 2009. Genzyme also applied for approval of Renvela tablets for dialysis patients in the key South American market of Brazil late last year, and will continue to pursue additional approvals internationally.
In the United States, Genzyme is engaged in active discussions with the Food and Drug Administration to expand Renvela's labeling to include chronic kidney disease patients with hyperphosphatemia who are not on dialysis. At the FDA's request, the three companies that currently market phosphate binders for dialysis patients are working collaboratively to provide information that will assist the agency in defining the appropriate earlier stage chronic kidney disease patient population.
Genzyme had previously a
|SOURCE Genzyme Corporation|
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