FDA Advisory Committee Makes Favorable Recommendation for Cervarix, GlaxoSmithKline’s…

FDA Advisory Committee Makes Favorable Recommendation for Cervarix, GlaxoSmithKline’s Candidate Cervical Cancer Vaccine

Reuters

September 9, 2009

PHILADELPHIA, Sept. 9 /PRNewswire-FirstCall/ — 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. 

MORE…

PG

Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.