Shire’s Hunter’s syndrome drug review decision delayed

British pharmaceutical company Shire has revealed that it has been granted an extension by the FDA of its review period Elaprase, its treatment for Hunter’s syndrome.

Hunter’s syndrome is a rare genetic disorder predominantly affecting boys, where one of the 11 enzymes required to break down glycosaminoglycans is not present. Glycosaminoglycans are long-chain carbohydrates that are produced in several of the body’s organs but they can harm many of the body’s tissues and disrupt mental development if they are left to build up.

Shire says the delay is so that the FDA can review additional data and analyses requested when they were discussing the labels with the company.

Matthew Emmens, chief executive of Shire, said: “Shire will continue to work closely with the FDA during this brief extension of the Elaprase review and through this cooperative effort we expect that Elaprase will be approved and launched by the third quarter 2006.”

“There is no existing treatment for patients with Hunter syndrome and Shire is confident that the FDA recognizes the importance of making ELAPRASE available to these patients,” he added.

According to health information website PatientPlus, Hunter’s syndrome occurs once in every 72,000 male live births. There are two main variants of the disease. Patients who suffer from the severe form have an average life expectancy of 12-years-old, although some may survive into their thirties, states the website.

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