GSK Submits Data for US Cancer Vaccine
Mon, 03/30/2009 - 7:51am
LONDON (AP) — GlaxoSmithKline PLC said Monday that it had submitted final data to support its application to market its cervical cancer vaccine in the United States. The U.S. Food and Drug Administration reviewed interim data from the study on the effectiveness of Cervarix. Following an FDA review of the latest data, a decision is expected over whether to approve the vaccine for use in the United States. "We are pleased to have reached this significant milestone for Cervarix. The data submitted to the FDA reaffirm our confidence in the vaccine's safety and efficacy profile," said Dr. Barbara Howe, vice president and director of Glaxo's North American Vaccine Development unit. The vaccine has been approved in more than 90 countries, and applications for its use have been submitted in more than 20 other countries. Cervarix vaccinates against human papillomavirus, a common cause of cervical cancer. Rival Merck & Co.'s Gardasil vaccine does that too and already has been approved for use in the United States.