Shire's Elaprase cleared in Mexico

UK drugmaker Shire's Elaprase (idursulfase), a human enzyme replacement therapy for Hunter syndrome, has been approved for commercial sale by the Mexican Federal Commission for the Protection against Sanitary Risk. Mexico is the 10th-largest pharmaceutical market in the world and the first Latin American country to approve the drug.

Hunter syndrome, also known as mucopolysaccharidosis II, is a serious, life-threatening genetic condition mainly affecting males that results from an absence of, or deficiency in, the lysosomal enzyme iduronate-2-sulfatase. Without sufficient amounts of this enzyme, cellular waste products accumulate in tissues and organs, which then begin to malfunction, leading to severe clinical complications and early mortality.

Elaprase, developed by Shire Human Genetic Therapies, is the first and only enzyme replacement therapy approved for the condition. The medicine is given as a weekly infusion and is designed to replace the deficient iduronate-2-sulfatase enzyme.