Mexico is the First Latin American Country to Approve Treatment
BASINGSTOKE, England and CAMBRIDGE, Massachusetts, February 13 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP)(NASDAQ: SHPGY)(TSX: SHQ), the global specialty biopharmaceutical company, announced that ELAPRASE(R) (idursulfase), a human enzyme replacement therapy for the treatment of Hunter syndrome, has been approved for commercial sale by the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS). Mexico is the tenth-largest pharmaceutical market in the world(1) and the first Latin American country to approve ELAPRASE.
Hunter syndrome, also known as Mucopolysaccharidosis II (MPS 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 (HGT), is the first and only enzyme replacement therapy approved for people suffering from Hunter syndrome. The medicine is given as a weekly infusion and is designed to replace the deficient iduronate-2-sulfatase enzyme.
"The approval of ELAPRASE in Mexico marks a significant milestone
because for the first time, Hunter syndrome patients in Mexico have access
to treatment," said Sylvie Gregoire, President of Shire HGT, the Shire
business unit focused on genetic diseases. "This approval also underscores
our dedication and commitment to provide meaningful treatments for patients
suffering from serious and often neglected diseases around
|SOURCE Shire plc|
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