Shire's Elaprase gets nod from EMEA's CHMP

UK drugmaker Shire says that the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMEA) issued a positive opinion recommending approval of its drug Elaprase (idursulfase) for the long-term treatment of patients with Hunter syndrome (mucopolysaccharidosis II). European Union marketing authorization is expected early in 2007 and will result in unified labeling that will be valid in the current 25 member states of the EU, as well as in Iceland and Norway.

According to the firm, Hunter syndrome is a very rare, life-threatening genetic condition that affects mostly males and results from the absence or deficiency of the lysosomal enzyme iduronate-2-sulfatase, without which cellular waste products accumulate in tissues and organs and begin to malfunction, resulting in life expectantcy of 10 to 20 years.

Elaprase was approved earlier this year in the USA by the Food and Drug Administration and early access has been granted to patients with Hunter syndrome in a number of European countries including Italy, Germany, Spain, France, Sweden, Denmark and Norway. Demand from patients' families and health care providers has been high and, as of October 19, 2006, 58 patients have already been infused with the treatment in these countries.