FDA Update

GSK Seeks Approval for HPV Vaccine

Last month, GlaxoSmithKline (GSK) submitted final data from a phase III study of its cervical cancer vaccine Cervarix to the FDA in a Biologics License Application (BLA).

The study, HPV-008, involved 18,600 women aged 15 to 25 years from 14 countries in Europe, Asia, and Latin and North America. According to a news release issued by the company, GSK will submit the data included in the BLA “to a peer-reviewed journal in the coming months.”   

BLA reviews are typically conducted within 6 months, GSK noted in the news release. If approved, Cervarix would be the second HPV vaccine available in the United States. Gardasil, manufactured by Merck, was approved in 2006.