Off-Label Safety Signal For Affymax's Peginesatide Doesn't Dissuade ODAC, With Assurance Of Restricted Distribution
There was a cardiovascular safety signal in two clinical trials of non-dialysis patients taking Affymax's peginesatide to treat anemia due to chronic kidney disease, but the Oncologic Drugs Advisory Committee concluded the drug's benefits are greater than its risks for patients on dialysis.
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Affymax's Peginesatide May Be Tough Sell To ODAC As ESAs Cast Long Showdow
Safety concerns over erythropoiesis-stimulating agents seem to extend to Affymax's peginesatide, and since it lacks an efficacy edges over these drugs in treating anemia due to chronic kidney disease, an approval basis is unclear.
Janssen’s Sirturo Needs Minor Tweaks To Confirmatory Trial, FDA Panel Says
Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.
Ranbaxy’s Atorvastatin Recall: Will Glass Shards Nick FDA’s Reputation?
Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.