The FDA has extended its 90-day review period for Shire's biologics license application (BLA) for Elaprase, a treatment for Hunter syndrome.
The extension will allow the agency additional time to review data and analyses that were recently requested during labeling discussions, the FDA said. The new date for a decision is Aug. 24, 2006.
Shire said it will continue to work closely with the FDA during the extension and expects to launch Elaprase (idursulfase) by the third quarter of this year.
Shire submitted the BLA in November 2005 and was granted priority review, requiring the FDA to take action within six months. A marketing authorization application for the medication has also been submitted to the European Medicines Agency and a response is expected before the end of the year, the company said.
Hunter syndrome is a rare genetic disorder, mainly affecting males, that interferes with the body's ability to break down and recycle specific chemicals called mucopolysaccharides. The toxic buildup of these chemicals in the body typically causes a coarse facial appearance, short stature, the abnormal function of multiple organs, and, in severe cases, early death.