First Drug for Hunter Syndrome Approved
Posted on: Monday, 24 July 2006, 15:00 CDT
Shire said Monday its drug Elaprase has been approved by the U.S. Food and Drug Administration to treat Hunter syndrome.
The company said Elaprase -- the first and only treatment approved for the condition -- is given in weekly infusions, replacing the missing enzyme that patients with Hunter syndrome fail to produce in sufficient amounts. Shire said it would launch the product within the next 30 days.
Hunter syndrome -- also called Mucopolysaccharidosis II (MPS II) -- is a rare, potentially fatal genetic condition caused by an insufficient production of the lysosomal enzyme iduronate-2-sulfatase, a deficiency that leads to the buildup of cellular waste products in the patient's tissues and organs, which in turn causes malfunction.
Shire said it expects to launch Elaprase in the United States within the next 30 days, adding that it expects European approval of the treatment by year's end.
Source: United Press International
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