FDA extends review period for Shire's Elaprase

The UK's Shire Pharmaceuticals says that the US Food and Drug Administration has extended by 90 days the review period for the Biologics License Application for its Hunter syndrome drug candidate Elaprase (idursulfase). This extension will allow the FDA additional time to review data and analyses it recently requested during label discussions. The agency has advised at close of US business May 16 that the new action date for the application is August 24.

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