BETHESDA, MD 25 February 2013—
Affymax Inc. and Takeda Pharmaceutical Company Limited
on February 23 announced a recall of all peginesatide vials because of reports of serious hypersensitivity reactions in patients who received the erythropoiesis-stimulating agent at dialysis centers.
Three patients died in February within 30 minutes of receiving their first i.v. dose of the drug, John A. Orwin, chief executive officer of Affymax, said during a conference call this morning.
Two patients had died earlier after their first i.v. dose, he said, but those deaths had initially been deemed not drug related.
Altogether, 5 patients have died and 14 other patients have had serious hypersensitivity reactions, including anaphylaxis, since FDA approved the marketing of peginesatide, Orwin said.
FDA approved Affymax's new drug application for peginesatide, or Omontys, in March 2012. The approval covered single-use vials, ready-to-use syringes, and multiple-dose vials.
Peginesatide's labeling describes one indication for use: treatment of anemia due to chronic kidney disease in adults undergoing dialysis.
Although the labeling states that peginesatide is given as a single i.v. or s.c. injection once monthly, Orwin said a limited number of patients have received the drug by s.c. injection.
Affymax's chief medical officer, Anne-Marie Duliege, reported during the conference call that only the multiple-dose vials have been distributed since approval of the drug product.
The clinical trials had used the single-dose formulation, she said.
Orwin said the 19 cases of serious hypersensitivity reactions were not linked to one lot of the drug. But all the reactions occurred within 30 minutes of the first i.v. dose.
The company as yet has not identified any patient-specific characteristic among the 19 cases, he said.
, in alerting health care providers to the recall of peginesatide, named Procrit, Epogen, and Aranesp as other erythropoiesis-stimulating agents that treat anemia.
All three products are manufactured by Amgen Inc., and all have labeling describing their use in the treatment of anemia due to chronic kidney disease in patients undergoing dialysis.
Affymax's collaboration with Takeda to develop peginesatide for commercial use dates back to 2006.