EMA recommends lifting of suspension of marketing authorization for Octapharma's octagam

Apr 15 2011

The Committee for Medicinal Products for Human Use (CHMP) of the The European Medicines Agency (EMA) has recommended today to lift the EU-wide suspension of the marketing authorizations of both octagam^® and octagam^®10% which has been in place since September 2010, subject to certain conditions.

The background to the suspension in September 2010 was an unexpectedly high number of reports of thromboembolic events in patients using the medicine.

The CHMP reviewed the company's investigations into the root cause of the problem and its proposed corrective measures and concluded the review with a recommendation that the suspension of the marketing authorisation for octagam^® be lifted in the EU on the basis of the safeguards and actions implemented by the company.

The Committee noted that appropriate corrective measures are now in place at the manufacturing sites. The CHMP also agreed on a test to be carried out to detect factor XIa or other substances that can cause thromboembolic events before batches are released onto the market. Octapharma will carry out post-marketing studies as soon as the medicine is reintroduced into the market in order to confirm the safety of the improved manufacturing process.

Octapharma was and is committed to provide their stakeholders with a family of IVIG preparations that offers the best possible value to patients and healthcare professionals and consequently manufactures octagam^® and octagam^® 10% according to the latest state of research in plasma fractionation.

The long term experience with the use of octagam^® over 17 years and octagam^®10% in over two years in the EU confirms the brand characteristics in terms of quality and tolerability.

Octapharma will start with the distribution of the two products in the EU as soon as all necessary administrative steps have been taken by EMA and the EU Commission.