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Dialysis Discussion => Dialysis: News Articles => Topic started by: okarol on October 24, 2011, 11:27:46 PM
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FDA sets date to review Affymax anemia drug
by Associated Press | Oct 24, 2011 10:55 AM ET
PALO ALTO, Calif. — Biotech drugmaker Affymax Inc. said Monday that the Food and Drug Administration has scheduled a meeting in December to review its experimental anemia drug for patients with anemia caused by chronic kidney disease.
The FDA will ask its panel of hematology experts to review the safety and effectiveness of the drug peginesatide at a Dec. 7 meeting. The FDA is not required to follow the group's advice, though it often does.
Affymax is seeking approval to market the drug to adult patients on kidney dialysis, who typically suffer from anemia, a blood disorder that causes dizziness and weakness.
Peginesatide is part of a class of drugs known as erythropoiesis stimulating agents, which boost the oxygen-carrying component of the blood. The three blockbuster anemia drugs currently sold in the U.S. are made by Thousand Oaks, Calif.-based Amgen Inc. The drugs' recommended starting regiment is three weekly injections.
Affymax says its drug would be the first once-monthly injection for anemia associated with chronic kidney disease.
Company shares rose 21 cents, or 4.1 percent, to $5.32 in morning trading.
Read more: http://moneywatch.bnet.com/economic-news/news/fda-sets-date-to-review-affymax-anemia-drug/6319533/#ixzz1blwjKvRz