SHIRE PLC - FDA Grants Priority Review for Shire,COs velaglucerase.

PR Newswire UK Disclose, November, 2009

 
FDA Grants Priority Review for Shire's velaglucerase alfa for Type 1 Gaucher 
Disease 
 
FDA issued action date of February 28, 2010 under the Prescription Drug User 
Free Act (PDUFA) 
 
 
Cambridge, MA - November 4, 2009 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the 
global specialty biopharmaceutical company, today 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. 
 
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....

            
        
    
    	    
                
                
	

		

					 
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