Shire's Elaprase cleared by US regulators

UK drugmaker Shire says that the US Food and Drug Administration has granted marketing approval for Elaprase (idursulfase), its human enzyme replacement therapy for the treatment of Hunter syndrome, also known as Mucopolysaccharidosis II. The rare, life-threatening genetic condition results from the absence or insufficient levels of the lysosomal enzyme iduronate-2-sulfatase, without which cellular waste products accumulate in tissues and organs, ultimately causing malfunction.

The agent is the first and only treatment approved for people suffering from Hunter syndrome. The product, which is given as weekly infusions, replaces the missing enzyme that Hunter syndrome patients fail to produce in sufficient quantities. Shire expects to launch the treatment in the USA within the next 30 days. The UK firm also submitted a Marketing Authorization Application for Elaprase to the European Medicines Agency (EMEA) in December 2005. Based on average evaluation times, Shire anticipates completion of the EMEA review by the end of the year.