Extraneal

Extraneal is a solution that is used in peritoneal dialysis. This is a blood clearance technique used in patients with long-term kidney failure, when a solution is pumped into the abdomen and an internal body membrane filters the blood.

Extraneal is a solution that contains icodextrin as the active substance, as well as sodium lactate, sodium chloride, calcium chloride and magnesium chloride. Icodextrin is a type of sugar that is used to keep blood glucose at the correct level. Extraneal is used in particular in patients who cannot be treated with solutions containing glucose.

Extraneal is authorised in the European Union under a mutual recognition procedure on the basis of the initial authorisation granted by the United Kingdom in 1997. The company applied for a change (variation) to the marketing authorisation to include a test to measure the level of an impurity called peptidoglycan during the medicine's production process. Peptidoglycans had been linked to cases of inflammation of the peritoneum (the lining of the abdomen) in some patients receiving Extraneal. This variation was to be recognised in Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain and Sweden (the concerned Member States). Because these Member States were not able to reach an agreement, the Dutch medicines regulatory agency referred the matter to the CHMP for arbitration on 9 July 2009.

The grounds for the referral were that more sensitive tests than those proposed by the company could be used to detect peptidoglycans in the medicine, and that one of the currently approved manufacturers of the active substance should modify the manufacturing process of icodextrin to ensure that peptidoglycans are removed.

Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the variation to the marketing authorisation for Extraneal can be approved in all concerned Member States.