LONDON, PHILADELPHIA, Dec. 17, 2007-GlaxoSmithKline (NYSE: GSK) announced today that it has received a complete response letter from the U.S. Food and Drug Administration related to its application for the cervical cancer vaccine, CERVARIX
A complete response letter is issued by FDA’s Center for Biologics Evaluation and Research (CBER) when the review of a file is completed and questions remain to be answered prior to approval. GSK will work closely with the FDA to prepare its response, which it intends to submit to the agency as soon as possible.
"We have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses,”said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "Our discussions with the agency continue to be positive and constructive, and we are working diligently to resolve any outstanding questions to bring CERVARIX®to the U.S.market.”
The application filed for the GSK cervical cancer vaccine included safety, efficacy and immune response data from clinical trials involving almost 30,000 females 10 to 55 years of age from ethnically and racially diverse populations.
To date, CERVARIX® has been approved in 45 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singaporeand the Philippines. Licensing applications have been submitted in more than 27 additional countries including Japan. GSK also submitted CERVARIX®to the World Health Organization (WHO) for prequalification in September 2007.
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