HES solutions should remain on the market

January 29, 2018

Fresenius Kabi does not concur with the position of the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) of the European Medicines Agency (EMA) to suspend the marketing authorisations of hydroxyethyl starch (HES) solutions for infusion in the European Union. Fresenius Kabi is convinced that HES products can be used safely and effectively in the approved indications.

The CMDh formed its position on the basis of two Drug Utilisation Studies (DUS) that retrospectively reviewed the adherence of hospital physicians to the 2014 revised European Product Information for HES products. The CMDh argued that HES products were used outside the approved indications or despite contraindications for certain patient groups. HES products have a positive benefit-risk ratio in approved indications. Therefore, a suspension would not be appropriate, but additional measures could be implemented to avoid off-label use of these products. Fresenius Kabi has proposed such measures in detail to the EMA.

Moreover, a group of renowned independent scientific experts recommended that HES products not be suspended, and voted by large majority in favor of keeping the products on the market. This ad hoc group of experts was set up by the Pharmacovigilance Risk Assessment Committee of the EMA and has concluded that HES products are well tolerated and effective therapeutic options for the treatment of hypovolaemia in surgical and trauma patients.

Fresenius Kabi strongly believes that it took appropriate measures to comprehensively inform health care professionals about the revised European Product Information for its HES products and is committed to implement further measures to increase adherence to it.

The CMDh member states did not reach a unanimous consensus, and the position has been forwarded to the European Commission for a decision. Fresenius Kabi is going to take legal actions in the event of a suspension of HES products, as these solutions should remain a therapy option for the benefit of patients.

Fresenius Kabi is a global health care company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. Fresenius Kabi’s product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the medical devices for administering these products. Within transfusion technologies, Fresenius Kabi offers products for collection and processing of blood components and for therapeutic treatment of patient blood by apheresis systems. In the field of biosimilars, Fresenius Kabi develops products with a focus on oncology and autoimmune diseases. With its corporate philosophy of "caring for life", the company is committed to putting essential medicines and technologies in the hands of people who help patients and finding the best answers to the challenges they face.

Fresenius Kabi employs over 35,000 people worldwide. In 2016 the company reported sales of about €6 billion. Fresenius Kabi AG is a wholly owned subsidiary of the Fresenius SE & Co. KGaA health care group.

For more information visit the Company’s website at www.fresenius-kabi.com

This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.

Management Board: Mats Henriksson (Chairman), Marc Crouton, John Ducker, Dr. Christian Hauer, Dr. Michael Schönhofen, Philipp Schulte-Noelle, Gerrit Steen
Chairman of the Supervisory Board: Stephan Sturm
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg - HRB 11654