Several deaths related to the kidney disease treatment Omontys have led to a recall of the injection in the US by Takeda and Affymax.
According to a joint statement released by the pharma companies, five people died after receiving Omontys (peginesatide) and suffering serious hypersensitivity reactions within 30 minutes following the first intravenous dose of the treatment.
There have also been a series of non-fatal allergic reactions, with the companies reporting that 0.2 per cent (about 50 people) suffered a hypersensitivity reaction.
Of this group, about a third have been ‘serious’, including some cases of anaphylaxis that required hospitalisation.
The recall is voluntary at the moment, with Takeda and Affymax working with the US FDA.
The regulator approved the drug in March last year to treat anaemia due to chronic kidney disease in adult patients on dialysis and since then Omontys has achieved more than $15m in sales, providing patients with a once-monthly alternative to Amgen’s Epogen (epoetin alfa), which requires dosing three times a week, or the second-generation product Aranesp (darbepoetin alfa) which can be given either weekly or every two weeks.
However, this recall puts the future of the drug in serious doubt, with healthcare professionals advised that no new or existing patients should receive the drug and the FDA moving to alert doctors and patients in the US to Takeda-Affymax’ recall.
“Due to the severity of the public health risk, we want to be certain that healthcare providers stop using Omontys,” said Howard Sklamberg, director, office of compliance, FDA’s Center for Drug Evaluation and Research.
“Americans deserve medications that are safe, effective, and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more.”
In a webcast following the recall, Affymax’s CEO John Orwin described the reported safety problems as a “surprising turn of events” considering the positive feedback they had received from customers.
He also advised on the future of the drug, saying: “At this point we are unable to prospectively identify which patients may be susceptible to hypersensitivity reactions. We are investigating potential ways to address this risk.
“If we can identify and address the underlying cause, the FDA has said it will work with us on appropriate next steps for the product.”