GlaxoSmithKline (GSK) has submitted for review a marketing application for Cervarix- the company's candidate vaccinefor cervical cancer - to the European Agency for the Evaluation of Medicinal Products (EMEA).
According to the company release, Cervarix has been developed to prevent infection from the two most prevalent cancer-causing types of the human papillomavirus (HPV), specifically HPV 16 and 18, which together are responsible for over seventy percent (70%) of cervical cancer globally.
In clinical trials, Cervarix was the first to demonstrate 100% protection from persistent infection against both HPV 16 and HPV 18 and protection from precancerous lesions. In the same trials, preliminary evidence of broader protection against other cancer-causing strains of HPV, in addition to HPV 16 and 18, was shown. Cervarix is formulated with the proprietary innovative adjuvant AS04, selected to ensure that Cervarix confers strong and sustained antibody levels in women.
Andrew Witty, President of GSK Pharmaceuticals Europe noted, "We developed this vaccine with the ambition to provide all women with the best possible protection against cervical cancer throughout their life and are delighted with the progress we are making towards bringing the vaccine to market. Our efforts demonstrate GSK's commitment to develop innovative products that have a major impact in preventing life-threatening disease for women."
GSK's international regulatory filings for Cervarix will follow in Australia, parts of Asiaand Latin Americafrom March 2006, with submission to the US Food and Drug Administration (FDA) by the end of 2006.