In continuing coverage, Bloomberg News 
(12/8, Peterson) reports that Affymax Inc "won a US panel's backing for
an experimental anemia medicine...for patients with chronic kidney
disease (CKD)."
(12/8, Peterson) reports that Affymax Inc "won a US panel's backing for
an experimental anemia medicine...for patients with chronic kidney
disease (CKD)."
MedPage Today
(12/8, Walker) reports that the Food and Drug Administration's
Oncologic Drugs Advisory Committee, by a vote of 15 to 1 with one
abstention, has recommended that "the synthetic
erythropoiesis-stimulating agent (ESA) peginesatide should be approved
as an anemia treatment option for chronic kidney disease (CKD) patients
who are on dialysis." The FDA advisory panel "concluded that
peginesatide, made by Affymax, appears to work as well as
currently-available ESAs to raise hemoglobin levels and reduce the need
for red blood cell
transfusions in patients on dialysis." MedPage Today points out, "The
FDA is not required to follow the advice of its advisory panels, but it
often does. If approved, peginesatide would not be indicated for
patients not on dialysis or patients with cancer."
(12/8, Walker) reports that the Food and Drug Administration's
Oncologic Drugs Advisory Committee, by a vote of 15 to 1 with one
abstention, has recommended that "the synthetic
erythropoiesis-stimulating agent (ESA) peginesatide should be approved
as an anemia treatment option for chronic kidney disease (CKD) patients
who are on dialysis." The FDA advisory panel "concluded that
peginesatide, made by Affymax, appears to work as well as
currently-available ESAs to raise hemoglobin levels and reduce the need
for red blood cell
transfusions in patients on dialysis." MedPage Today points out, "The
FDA is not required to follow the advice of its advisory panels, but it
often does. If approved, peginesatide would not be indicated for
patients not on dialysis or patients with cancer."
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