Affymax, Inc. (AFFY) announced that the U.S. Food and Drug Administration's, or FDA's, Oncologic Drugs Advisory Committee will review the New Drug Application for peginesatide proposed for the treatment of anemia associated with chronic kidney disease in adult patients on dialysis on December 7, 2011 during the afternoon session. The FDA has established an action date of March 27, 2012 under the Prescription Drug User Fee Act, the company noted.
Affymax said it plans to begin a self-imposed quiet period on November 16, 2011 in anticipation of receipt of FDA briefing documents and added that the quiet period will continue until after the Advisory Committee meeting is completed. If approved, peginesatide will be the first once-monthly Erythropoiesis stimulating agent available for the treatment of anemia associated with chronic kidney disease patients on dialysis in the US.
For comments and feedback contact: editorial@rttnews.com
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.