More data requested.Thousand Oaks-based Amgen Inc. hopes to convince U.S. regulators to consider expanded data from existing clinical trials when deciding whether to approve a monthly dose of its anemia drug Aranesp for patients with chronic kidney disease Chronic kidney disease (CKD), also know as chronic renal disease, is a progressive loss of renal function over a period of months or years through five stages. Each stage is a progression through an abnormally low and progressively worse glomerular filtration rate, which is who are not on dialysis dialysis (dīăl`ĭsĭs), in chemistry, transfer of solute (dissolved solids) across a semipermeable membrane. Strictly speaking, dialysis refers only to the transfer of the solute; transfer of the solvent is called osmosis. . The U.S. Food and Drag Administration requested the additional data this month. In lieu of a new trial, Amgen is asking the agency to accept additional data gathered since the application was first submitted in December 2005. Amgen reported combined sales of Aranesp and its predecessor Epogen of $6 billion last year. For patients with kidney disease Kidney Disease Definition Kidney disease is a general term for any damage that reduces the functioning of the kidney. Kidney disease is also called renal disease. the cost of Aranesp, typically on twice-monthly dosing, can range from $4,000 to $5,000 a year, according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the company. |
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