FDA advisory committee favorably reviews Cervarix
PHILADELPHIA A Food and Drug Administration advisory committee has given a favorable review to a new cervical cancer vaccine.
GlaxoSmithKline announced that the FDA’s Vaccines and Related Biological Products Advisory Committee voted that data from clinical trials support the efficacy and safety of Cervarix (human papillomavirus bivalent [types 16 and 18] vaccine, recombinant), which the company hopes to market as a competitor to Merck & Co.’s Gardasil (human papillomavirus quadrivalent [types 6, 11, 16 and 18] vaccine, recombinant).
“This is an important step in cancer prevention for the millions of girls and young women at risk for cervical cancer,” GSK director and VP North American vaccine development Barbara Howe said in a statement. “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 vaccine works by preventing infection by human papillomavirus types 16 and 18, the two most common strains that cause cervical cancer.