FDA approves GSK's HPV vaccine

PHILADELPHIA Merck & Co.’s highly successful human papillomavirus vaccine Gardasil has a new competitor.

The Food and Drug Administration approved GlaxoSmithKline’s Cervarix (human papillomavirus bivalent [types 16 and 18] vaccine, recombinant), for preventing infection by HPV – the virus that causes genital warts and can cause cervical cancer – in girls and women ages 10 to 25.

“The approval of Cervarix will bring an important new cervical cancer vaccine to girls and young women,” GSK president North American pharmaceuticals Deirdre Connelly said in a statement. “Immunization with a vaccine such as Cervarix – along with annual doctor visits and Pap tests – will help protect women from cervical cancer, the second leading cause of cancer death in women in their 20s and 30s.”

The FDA has already approved Merck’s Gardasil (human papillomavirus quadrivalent [types 6, 11, 16 and 18] vaccine, recombinant) for females and males ages 9 to 26.