Octagam 5% human IV immunoglobulin regulatory update

European Medicines Agency (EMA) recommended marketing suspension and a recall of Octapharma's Octagam 5% and 10% human IV immunoglobulin in the EU after an increased number of thromboembolic events were reported in patients receiving the drug. Additionally, the company said it is withdrawing, at the request of FDA, all lots of Octagam 5% from the U.S. market. On Aug. 20, the company voluntarily withdrew a total of 31 selected lots of the drug. The company said it has not received any further reports of thromboembolic events since Aug. 20, but has decided to suspend marketing until the cause of the events can be determined and corrected (see BioCentury, Sept. 6).

The company also said it disagrees with EMA's recommendation to suspend marketing authorization of both the 5% and 10% doses, since no thromboembolic events have been reported to date in patients receiving Octagam 10%. ...