Fresenius Medical Care releases new adsorber IgEnio® in Europe for treatment of severe allergic symptoms

Fresenius Medical Care has released a new single-use adsorber for the treatment of IgE (ImmunoglobulinE)-mediated diseases in the European market.

Latest epidemiological data shows that IgE-mediated diseases affect more than 25 percent of the world’s population. Of this group, an estimated 10 percent suffer from severe allergic symptoms such as asthma and atopic dermatitis. The new adsorber, called IgEnio®, is intended to provide a therapy option for these patients.

IgEnio® complements the growing portfolio of Fresenius Medical Care’s Therapeutic Apheresis business, which already offers adsorbers targeting the reduction of ImmunoglobulinG (a therapy for autoimmune diseases) and the removal of other, specific pathogens.

IgEnio® was developed on the basis of Fresenius Medical Care’s longstanding expertise in extracorporeal treatments, and represents a further step in the strategic expansion of this important therapy field. IgEnio® was co-developed with Biomay AG, a global leader in allergy immunotherapy products, based in Vienna.

The clinical results of IgEnio® were presented for the first time at a scientific congress in Barcelona in June. IgEnio® will be introduced in selected markets – France, Germany, Italy, Spain and the United Kingdom – in the course of 2015. Fresenius Medical Care will continue the rollout within its Europe, Middle East and Africa region.

The IgE synthesis pathway and the IgE-mediated allergic/inflammatory pathway are important targets in intervening in the pathological processes of allergy. IgEnio® is a single-use, single-pass adsorber that selectively decreases IgE levels in the plasma. The first clinical trial of IgEnio®, called ESPIRA, included patients with severe allergic asthma not sufficiently controlled by inhaled steroids and other medications. These patients, who have high IgE levels in their plasma, currently have very limited treatment options.

The primary end point of the ESPIRA study was to reduce IgE levels by more than 50 percent over the treatment period and to demonstrate safe application in clinical practice. Within the study, patients underwent nine apheresis treatments with IgEnio®, with each treatment lasting for approximately four hours. As a result of the treatments, a highly significant reduction of more than 80 percent in plasma IgE was observed (p<0.001). For highly allergic patients in the ESPIRA study setting, lgEnio® was safe and well tolerated.

To strengthen the scientific evidence base and to create more clinical expertise, Fresenius Medical Care will conduct further clinical investigations in the coming years.