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December 17, 2007 LONDON (Reuters) - GlaxoSmithKline Plc's cervical cancer vaccine Cervarix faces a delay in winning approval in the United States, putting it further behind Merck & Co Inc's rival product Gardasil, which is already available. Glaxo, Europe's biggest drugmaker, said on Monday it had received a "complete response letter" from the U.S. Food and Drug Administration (FDA), which is issued when the regulator has completed the review of a medicine, but still has questions. Analysts, who had been expecting the FDA to issue a decision on Cervarix by next month, said the setback would delay approval by at least a few months and possibly more than a year. "GSK will work closely with the FDA to prepare its response, which it intends to submit to the agency as soon as possible," Glaxo said in a statement. Cervarix is already approved in 45 countries, including the 27 member states of the European Union. But it is trailing Merck's Gardasil, which is already well established in the United States -- the world's biggest drug market. A Glaxo spokesman declined to comment on when a final U.S. decision on Cervarix might now be made. In cases such as this, the regulator usually takes up to six months to respond, once it has received the answers to its questions. Glaxo is not disclosing what the outstanding questions are or how long they will take to answer. Both Cervarix and Gardasil protect against cancer-causing strains of the sexually transmitted human papillomavirus (HPV) and are designed to be given to girls and young women. Gardasil targets four strains of HPV, while Glaxo's product targets two. Copyright 2008 Reuters. Click for Restrictions.
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