Glaxo says FDA grants priority review for blood disorder drug

Mon Mar 3, 2008 8:20am EST
 
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March 3 (Reuters) - British drugmaker GlaxoSmithKline (GSK.N) (GSK.L) said U.S. health regulators have granted priority review for its experimental drug promacta to treat patients with chronic ITP, a disorder that destroys platelets in the blood.

A priority review means the U.S. Food and Drug Administration is likely to decide within six months whether to approve the treatment, rather than the usual 10-month review period.

Glaxo plans to submit this year a marketing application for the drug in Europe, where it will be sold as revolade. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Pratish Narayanan)

 
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