Shire requests FDA approval of Fabry disease drug

AP News
Posted: Dec 22, 2009 12:17 PM

British drugmaker Shire PLC said Tuesday it filed for U.S. marketing approval of its Fabry disease treatment Replagal.

Replagal is available under Food and Drug Administration restrictions, and the company is seeking full approval. The drug has been on the market in Europe since 2001, Shire said. It treats an inherited disorder caused by the buildup of a particular type of fat in the body's cells.

Shire also said the FDA has completed pre-approval inspections of Shire facilities in Cambridge and Lexington, Mass. Those inspections are part of the FDA's review of velaglucerase alfa, a drug that is intended to treat Gaucher disease. The agency is scheduled to make a ruling on velaglucerase alfa by Feb. 28, 2010.

Bring Out Your Dead
Gil Gutknecht

Gaucher disease is an enzyme disorder that can cause liver and neurological problems.

In morning trading, Shire stock lost 3 cents to $57.37.