The US Food and Drug Administration has extended the review period by 90 days for Elaprase, Shire’s candidate therapy for Hunter syndrome, a serious genetic disorder primarily affecting males.
The decision was made to give US regulators extra time to assess the additional data asked for during label discussions on Elaprase (idursulfase). A new action date has been set for August 24.
“We expect that Elaprase will be approved and launched by the third quarter of 2006,” commented Matthew Emmens, Shire’s Chief Executive Officer. “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.”
Hunter syndrome, also known as MPS II, is a rare, life-threatening genetic disorder with no available treatment. As the disease progresses, a variety of symptoms appear including, enlarged liver and spleen, and heart failure. If approved, Shire’s drug would be the first on the market to treat the disorder, which affects around 2,000 people worldwide.
The group as also filed an application to market the drug with the European Medicines Agency, and is expecting a response by year-end.