GSK Receives Complete Response Letter for Cervarix
GlaxoSmithKline (GSK) has received a complete response letter from the FDA related to its application for the cervical cancer vaccine Cervarix.
The application included safety, efficacy and immune response data from clinical trials involving almost 30,000 females 10–55 years of age, according to GSK.
The drug is approved in 45 countries, including the European Union, Mexico, Australia, Singapore and the Philippines. GSK also submitted Cervarix to the World Health Organization for prequalification in September.
The company will work with the FDA to prepare its response, which it intends to submit to the agency shortly.