Shire sees Elaprase receive approval in Mexico

Shire has seen its human enzyme replacement therapy Elaprase (idursulfase) approved in Mexico for the treatment of Hunter Syndrome.

The Mexican Federal Commission for the Protection against Sanitary Risk gave authorisation for commercial sale of the drug – becoming the first Latin American country to approve Elaprase.

Eleprase was developed by Shire Human Genetic Therapies (HGT) and is the first and only enzyme replacement therapy indicated for the treatment of Hunter Syndrome.

It was first approved in the US in July 2006 and since then has become available in 37 countries worldwide including Japan and a number of European countries.

Sylvie Gregoire, president of Shire HGT, described the decision by the Mexican regulatory authority as a “milestone” for Hunter Syndrome patients in Mexico.

“This approval also underscores our dedication and commitment to provide meaningful treatments for patients suffering from serious and often neglected diseases around the world,” she added.

Shire has confirmed that the Mexican product launch of Elaprase is likely to take place within the first half of 2008.

Last month, Shire announced that it had completed its roll-out of Fosrenol (lanthanum carbonate) in the major European markets