GlaxoSmithKline said it has received a complete response letter from the US 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, vice president and director, North American Vaccine Development, GSK. "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 US 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 EU, Mexico, Australia, Singapore and the Philippines.