UPDATE 2-Glaxo resubmits Cervarix to U.S. regulators

Mon Mar 30, 2009 3:32pm BST
 
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* Final data from Phase III study submitted to FDA

* U.S. approval possible in around six months

* Shares up 1.3 percent

(Adds further details, sales, background)

By Ben Hirschler

LONDON, March 30 (Reuters) - GlaxoSmithKline Plc (GSK.L) has resubmitted its cervical cancer vaccine Cervarix to U.S. regulators, with the inclusion of final data from a pivotal Phase III study, it said on Monday.

The filing with the Food and Drug Administration clears the way for potential approval in the all-important U.S. market in around six months.

Shares in the world's second largest drugmaker rose 1.3 percent after the news.

Cervarix, which is already approved in more than 90 countries around the world, including major European markets, competes with Merck & Co Inc's (MRK.N) Gardasil in protecting against the sexually transmitted cancer-causing human papillomavirus.   Continued...

 

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