Health Canada recently granted Shire HGT regulatory approval for Elaprase, indicated for enzyme replacement therapy in patients with Hunter syndrome.
Hunter syndrome is an X-linked recessive disorder caused by a deficiency or absence of iduronate-2-sulfatase (I2S). Its absence results in a harmful accumulation of cellular waste products in cells throughout the body. Hunter syndrome is one of a group of extremely rare hereditary metabolic diseases known collectively as lysosomal storage disorders.
Elaprase is designed to treat the underlying cause of Hunter syndrome by replacing I2S. The drug is a purified form of human I2S produced by recombinant DNA technology using a human cell line.
“Hunter syndrome is a devastating condition and we are pleased to expand our partnership with Shire,” said Jonathan Ross Goodman, president and CEO of Paladin. “Elaprase is now available in Canada.”