Probe launched as deaths prompt Omontys recall
pharmafile | February 26, 2013 | News story | Manufacturing and Production | Affymax, Takeda, omontys, recall
Reports of three fatal reactions linked to administration of Takeda and Affymax’ Omontys anaemia treatment have led to a recall of the drug and an investigation into possible root causes.
All lots of Omontys (peginasetide) sold in 10mg and 20mg vials have been recalled, said the two companies, who noted that the patients died after receiving first-dose intravenous injection with the drug.
There have been no reports of such reactions following subsequent dosing in patients who have completed their dialysis session, or in patients receiving the drug subcutaneously, although Affymax noted that the number of patients receiving it subcutaneously remains limited.
The fatalities appear to have been caused by serious allergic reactions – including anaphylaxis – and Takeda and Affymax have warned healthcare providers not to prescribe Omontys while the root cause is being investigated.
The records of the patients who died are being examined to see if there is any common characteristic that could explain the reactions, while manufacturing, the handling of the product in the supply chain and practices at dialysis centres where the drug was administered are also being examined.
On a conference call, Affymax chief medical officer Anne-Marie Duliege noted that 25,000 patients have been treated with Omontys since launch, with hypersensitivity reactions seen in 0.2% of cases. This was about the same rate as seen in clinical trials, but the seriousness of the reactions was considerably less during testing, she added.
Clinical testing was carried out on single-dose vials, and the reactions have occurred among patients treated with Omontys taken from multidose vials, but Affymax stressed on the call that it is too early to speculate on possible manufacturing issues or other causes.
Omontys was launched in the US less than a year ago as the first competitor to Amgen’s Epogen (epoetin alfa) blockbuster, and achieved sales of around $15 million in the third quarter of 2012, according to Takeda.
Take-up of the drug has disappointed analysts, given its favourable once-per-month dosing schedule compared to Amgen’s drug. The two companies will share the cost of recall.
Phil Taylor
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