LONDON, July 18 (UPI) -- British drug giant GlaxoSmithKline said Wednesday its cervical cancer vaccine candidate Cervarix has been recommended for approval in Europe.
Glaxo said the European Committee for Human Medicinal Products has advised clearance of the vaccine for the prevention of precancerous lesions and cervical cancer caused by human papilloma virus types 16 and 18, the strains responsible for more than 70 percent of all cervical cancers.
The company said it has tested the treatment in nearly 30,000 women, including what it says is the largest phase 3 study of a cervical cancer vaccine to date.
The proposed indication is supported by data from studies in girls and women aged 10 to 25 years.
"Today's positive opinion from the CHMP is great news for women across Europe. It is a significant step towards achieving our ambition -- to provide women with protection against cervical cancer. Coupled with the excellent clinical trial results published recently, this news is further evidence of the great potential of our cervical cancer candidate vaccine," said JP Garnier, Glaxo's chief executive officer.
The company said full EU approval could come within the next few months. Cervarix has not yet received U.S. approval. Merck's Gardisil -- approved last year -- is currently the only cervical cancer vaccine on the U.S. market.
