Genzyme Kidney Drug Gets Positive European Opinion
Fri, 03/20/2009 - 6:39am
CAMBRIDGE, Mass. (AP) — Biotechnology company Genzyme Corp. said Thursday a European advisory committee recommended approving the company's drug Renvela as a treatment for patients with chronic kidney disease, including patients not on dialysis. The drug is already approved in the U.S. to control serum phosphorus in patients with chronic kidney disease on dialysis. Serum phosphorus is a chemical used by the body to get energy from food. The positive recommendation by the European Medicines Agency's Committee for Human Medicinal Products, or CHMP, will be taken into account by the European Commission when reviewing the application for approval. Like its U.S. counterpart, the European Commission generally follows the recommendations of its advisers, though it is not obligated. Genzyme said its European application includes both tablet and powder formulations of the drug.