It's been two years in the making, but GlaxoSmithKline has finally filed its last data submission to the FDA for the HPV vaccine Cervarix. And Glaxo is optimistic that a U.S. approval will greatly expand its market for the jab.
"The data submitted to the FDA reaffirm our confidence in the vaccine's safety and efficacy profile," said Barbara Howe, vice president and director of Glaxo's North American Vaccine Development unit.
Glaxo had tried in vain to get an accelerated approval for the cervical cancer vaccine in 2007, but was significantly delayed by the agency's demand for more long-term data. Since then, Cervarix has won approvals in more than 90 countries around the globe along with the European Union. In the U.S., though, Merck's Gardasil has been commanding market share as Glaxo researchers gathered new data. Now Gardasil's U.S. sales have begun to decline as its target audience of girls makes a decision for or against the vaccine.
Nevertheless, repeated studies have affirmed that these vaccines offer significant protection against cervical cancer and new efforts are underway to expand the market. Glaxo should hear back from the FDA in about six months.
- check out GSK's release
- read the report from the News & Observer
ALSO: Allergy Therapeutics says that an approval of Cervarix in the U.S. would bode well for its Pollinex Quattro hayfever vaccine, which uses the same adjuvant included in the HPV jab and is under a clinical hold as the agency reviews the use of adjuvants. Report