GlaxoSmithKline's CERVARIX receives favorable recommendation from FDA Advisory Committee

Sep 10 2009

GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that clinical data support both the efficacy and safety of CERVARIX((R)), the company's candidate cervical cancer vaccine (12-1 and 11-1, respectively).

CERVARIX was shown to be highly effective and well tolerated in girls and young women for the prevention of cervical pre-cancers and cervical cancer related to human papillomavirus (HPV) types 16 and 18, the two most common virus types that cause cervical cancer. The committee also discussed data demonstrating the efficacy of CERVARIX against additional cancer-causing virus types.

"This is an important step in cancer prevention for the millions of girls and young women at risk for cervical cancer," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "If approved, CERVARIX will help provide protection against cervical cancer, a devastating disease that is responsible for thousands of deaths in U.S. women each year."

The Committee's favorable recommendation, although not binding, will be considered by the FDA in its final review of the Biologics License Application (BLA) for the candidate vaccine. If approved, the FDA will determine final prescribing information.

In clinical trials, the most common side effects after vaccination with CERVARIX included pain, redness and swelling, fatigue, headache, joint and muscle aching, gastrointestinal symptoms and fever. Serious adverse events were generally comparable between the groups receiving CERVARIX and the control groups.

In March 2009, GSK submitted final data from its Phase III pivotal study (HPV-008), the single largest efficacy trial of a cervical cancer vaccine to date. The file included data from clinical trials in more than 30 countries involving nearly 30,000 participants receiving CERVARIX, which reflect an ethnically and racially diverse population and a broad range of women. It also included a thorough safety assessment relevant to 10-25 year old girls and young women.