Octagam 5% Returns to Market in U.S. and Europe

The U.S. Food and Drug Administration (FDA) and the Committee for Medicinal Products for Human Use in Europe have approved the return of Octagam 5% (human normal immunoglobulin 50 mg/ml) to the market. Marketing authorization was suspended in August 2010 in the U.S. and in September 2010 in Europe after a massive voluntary recall by Octapharma due to an increase of thromboembolic events (TEEs). To determine the biochemical root cause(s) of the TEEs in concerned Octagam batches, Octapharma conducted a number of tests, which identified FXIa as the major procoagulant activity. In response, FXIa was successfully removed through corrective and preventive measures in the manufacturing process.

Octapharma then conducted a 10- month product analysis of its Octagam 5% and Octagam 10% that confirmed an enhanced level of safety. “Industry-wide, immune globulin products can lead to TEEs in approximately one individual or less for every 10,000 treatments,” said Octapharma Chairman Wolfgang Marguerre. “But our analysis indicates that Octagam 5% and Octagam 10% outperformed this industry benchmark with no reported TEEs in approximately 60,000 patient treatments.”

Octapharma has now implemented post-marketing studies to ensure product safety. “Our collaboration with the FDA over the last year has enhanced awareness of the industry-wide concerns regarding procoagulant activity and TEEs,” said Octapharma USA President Flemming Nielsen. “Octapharma has always believed that patient safety comes first, so the Octagam 5% that we will return to the U.S. market … will enjoy the highest level of safety scrutiny available today and the same level of tolerability that our patients have come to expect from Octapharma therapies.”