The likelihood of GlaxoSmithKline’s Cervarix reaching the US market has been given a boost after the company said it has submitted final data from a key study of the cervical cancer vaccine to the Food and Drug Administration.
The UK drugs major confirmed that it has filed final data from its Phase III pivotal efficacy study, HPV-008, to the FDA. The agency had issued a complete response letter in December 2007 asking for more information after it reviewed interim data from the aforementioned trial.
Then last July, GSK said that as well as answering the FDA’s queries it had decided to augment its application with final data from HPV-008. The study involved more than 18,600 women between 15-25 years of age, and assessed vaccine efficacy in the prevention of high-grade pre-cancerous cervical lesions caused by human papillomavirus types 16 or 18.
GSK said it will submit the data to a peer-reviewed journal in the coming months and noted that it expects the FDA’s review of the Biologics License Application for Cervarix to take six months. Barbara Howe, GSK’s director of North American vaccine development, said the submission is a “significant milestone for Cervarix” and the data submitted to the FDA “reaffirm our confidence in the vaccine’s safety and efficacy profile”.
Cervarix has been approved in more than 90 countries, including the 27 member countries of the European Union, and licensing applications have been submitted in 20 more, including Japan. However in the USA, if approved, it would have a lot of ground make up on Merck & Co’s rival jab Gardasil, which is well-established across the Atlantic.
Cervarix sales last year were $177 million, while Gardasil brought in $286 million for Merck in the fourth quarter alone. However, that latter figure was down 16% on the like, year-earlier period.
