Shire: FDA Grants Priority Review For Shire's Velaglucerase
LONDON -(Dow Jones)- Shire PLC (SHP.LN), a global specialty biopharmaceutical
company, Wednesday announced that the United States Food and Drug Administration
(FDA) has granted Priority Review for the New Drug Application (NDA) for
velaglucerase alfa, the company's enzyme replacement therapy in development for
the treatment of Type 1 Gaucher disease.
MAIN FACTS:
-Priority Review designation is given to drugs that offer major advances in
treatment, or provide a treatment where no adequate therapy exists, and
accelerates the target review timing from ten to six months. The FDA has issued
an action date for the NDA of February 28, 2010 under the Prescription Drug User
Fee Act (PDUFA).
-In the U.S., patients continue to be enrolled in an FDA-approved treatment
protocol, under which Gaucher patients receive velaglucerase alfa prior to
commercialization.
-Shire has also engaged with national and regional authorities outside the
U.S. and patients are receiving velaglucerase alfa through pre-approval access
programs. Shire confirms it is on track with its filing of the Marketing
Authorization Application (MAA) in the E.U. for 2009.
-By London Bureau, Dow Jones Newswires; Contact Ian Walker; +44 (0)20 7842 9296;
ian.walker@dowjones.com
(END) Dow Jones Newswires
11-04-090718ET
Copyright (c) 2009 Dow Jones & Company, Inc.
|