Merck & Co Inc's Gardasil, the first vaccine to prevent cervical cancer, has been approved for sale in the European Union, the joint venture that will market the product in Europe said on Friday.
The move, which had been expected after a panel of European experts endorsed the vaccine in July, clears the way for Gardasil's launch before the end of October and brings mass vaccination against the killer disease a step nearer.
Gardasil, viewed by analysts as a multibillion dollar a year seller, is a new kind of vaccine that prevents cervical cancer by protecting against the sexually transmitted human papilloma virus (HPV) which can trigger tumours.
It is already approved in the United States and several other countries. It will be sold in Europe by Sanofi Pasteur MSD, a joint venture between Merck and Sanofi Aventis.
We will start the launch in the first country (in Europe) before the end of October. Our objective is to have the product available as quickly as possible, Didier Hoch, the president of Sanofi Pasteur MSD, told Reuters in a telephone interview.
Germany, Britain, the Netherlands and the Nordic countries would be among the first markets, he added.
The European approval for Gardasil came just nine months after it was first submitted for regulatory clearance an unusually short review time for new drugs and vaccines.
GlaxoSmithKline has a rival product called Cervarix waiting in the wings, which is slightly behind in development.
Cervarix was filed for approval in Europe in March and Glaxo aims to submit it for approval in the United States before the end of this year.