Cervarix US approval delayed
pharmafile | December 19, 2007 | News story | Research and Development, Sales and Marketing |Â Â Â
GlaxoSmithKline's cervical cancer vaccine Cervarix has suffered a setback in the US, where regulators have refused to approve it until the company provides more information.
It is a further blow for GSK after earlier clinical delays allowed a rival vaccine, Merck's Gardasil, to beat it to market, launching in the US and Europe in 2006.
The FDA has issued GSK with a 'complete response letter' detailing the questions it wants answers before it will clear Cervarix for launch.
The company said it will work closely with the US regulator and would submit its response to the agency as soon as possible.
Director of GSK's North American Vaccine Development Barbara Howe said: "We have already started addressing the questions and will be engaged in discussions with the FDA to finalise our responses.
"Our discussions with the agency continue to be positive and constructive, and we are working diligently to resolve any outstanding questions to bring Cervarix to the US market."
Cervarix received European approval in September and to try and gain some of the ground it has already lost to its rival, GSK initiated a head-to-head trial of Cervarix and Gardasil in January this year.
Its main aim will be to compare the vaccines' immune responses to HPV types 16 and 18 in women aged 18 to 26, with secondary goals of assessing responses in those aged 27 to 35 and 36 to 45.
One key claim Cervarix has over its rival is that it is formulated with a new technology which enhances the immune response and increase the duration of protection against cancer-causing virus types.
In Europe Cervarix is indicated for the prevention of precancerous cervical lesions and cervical cancer causally related to human papillomavirus (HPV) types 16 and 18.
Although there are around 100 types of HPV, types 16 and 18 are responsible for more than 72% of all cervical cancers in Europe, where cervical cancer is the second most common cause of death from cancer (after breast cancer) among women aged 15-44.
