Shire Gaucher drug gets FDA priority review
Shire PLC said that the Food and Drug Administration granted the company's developing treatment for Gaucher disease a priority review.
Gaucher disease is a rare enzyme disorder that can cause liver and neurological problems.
The FDA designation speeds up the regulatory review process for drug candidate, velaglucerase alfa, to six months from the usual 10. The FDA is scheduled to make decision by Feb. 28.
Shares of Shire, which is based in Ireland, slid 15 cents to $52.63 in morning trading.
(The market leader for the treatment of Gaucher is made by Genzyme Corp. The Cambridge biotechnology company has been rationing its treatment, called Cerezyme, after a virus was found in its Allston plant earlier this year. Production at the plant was temporarily suspended so equipment could be decontaminated. Production has since resumed.).







