Affymax, Inc. (AFFY) and Takeda Pharmaceutical Co. Ltd. said Wednesday that an advisory committee of the U.S. Food and Drug Administration has voted in favor of the benefit/risk profile for Peginesatide for the treatment of anemia in chronic kidney disease patients on dialysis.
Peginesatide, formerly known as Hematide, is a synthetic peptide-based erythropoiesis stimulating agent, or ESA, designed to stimulate production of red blood cells.
If approved by the U.S. Food and Drug Administration or FDA, the experimental drug that is co-developed by Affymax and Takeda Pharmaceutical Co. would compete with Amgen Inc.'s (AMGN) blockbuster anemia drug Epogen.
Affymax and Takeda Pharma said that the FDA's Oncologic Drugs Advisory Committee voted 15 to 1, with 1 abstention, that peginesatide's benefits outweighed its potential risks for use in the treatment of dialysis patients with anemia due to chronic kidney disease or CKD.
While the FDA is not bound by the recommendations of its advisory committees, their guidance will be considered by the FDA in its review of the New Drug Application NDA that was submitted for peginesatide in May 2011.
The FDA's final decision on Peginesatide is scheduled to be announced on March 27, 2012. If approved, Peginesatide will be the first once-monthly ESA available for the treatment of anemia associated with chronic kidney disease patients on dialysis in the U.S.
Erythropoiesis, the process by which red blood cells are developed within the red bone marrow, is aided by erythropoietin, a protein produced by the kidney. Sometimes, due to illnesses such as cancer, kidney disease and HIV, the rate of erythropoiesis is reduced below the normal resulting in anemia. This anemia is treated by synthetic ESAs, which are an artificial version of the natural protein erythropoietin.
Amgen's Epogen was the first ESA approved by the FDA in 1989 for the treatment of anemia in renal disease. In 1993, Epogen was approved for a supplemental indication for the treatment of anemia associated with cancer chemotherapy.
Some of the other FDA-approved ESAs include, Amgen's Aranesp, Johnson & Johnson's (JNJ) Procrit and Swiss drug major Roche's Mircera. Roche's NeoRecormon, approved in the EU, is also an ESA.
AFFY closed Wednesday's trading at $5.86, up $0.48 or 8.88 percent on a volume of 968,491 shares.
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