European Medicines Agency unit says Octagam suspension should be lifted

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the lifting of the suspension of the marketing authorizations for Octagam (human normal immunoglobulin 5% and 10%) and associated names, and the re-introduction of the medicine onto the market in the European Union. The lifting of the suspension is subject to a change to the manufacturing process.

Octagam, from Switzerland-based Octapharma, is an intravenous solution used to strengthen the body's immune system to lower the risk of infection in patients with a weakened immune system.  he CHMP recommended the suspension of the marketing authorisations for Octagam last year (The Pharma Letter September 26, 2010), following an unexpected increase in reports of thromboembolic reactions, including stroke, myocardial infarction (heart attack) and pulmonary embolism (clot in a blood vessel supplying the lungs) in patients receiving the medicine.

An in-depth review of all available data on the safety and quality issues identified previously has now been finalized. In the review, the CHMP concluded that the unexpected presence of a procoagulant, factor XIa, was the main cause of the thromboembolic events and that a number of critical steps in the manufacturing process could explain the presence of substances that triggered the thromboembolic events.