Sanofi Pasteur MSD Seeks to Expand Gardasil Indication in Europe

Sanofi Pasteur MSD has submitted data to the European Medicines Agency (EMEA) in an effort to add to the indications for its cervical cancer vaccine, Gardasil.

The new data come from large Phase III clinical studies, which enrolled more than 17,000 women and show that Gardasil provides protection against precancerous and potentially precancerous cervical lesions caused by human papillomavirus (HPV) types not directly targeted by the vaccine. The other HPV types cause more than 10 percent of cervical cancer and substantial proportions of precancerous and potentially precancerous cervical lesions, the company said.

In Europe, Gardasil is currently indicated for use in women to prevent cervical carcinoma, high-grade cervical dysplasia, high-grade vulvar dysplastic lesions and external genital warts caused by HPV types 6, 11, 16 and 18. In addition, Gardasil is efficacious in preventing potentially precancerous lesions caused by the virus types 6, 11, 16 and 18, which cause the majority of genital HPV diseases.

"Throughout the clinical development for Gardasil we have focused on proving efficacy against ... clinically relevant endpoints, including precancerous cervical lesions, for demonstrating the prevention of cervical cancer," Patrick Poirot, vice president of medical and scientific affairs at Sanofi Pasteur MSD, said. Sanofi Pasteur MSD is a joint venture between sanofi pasteur, the vaccine division of sanofi-aventis, and Merck.

Earlier this month, Merck announced the submission of the new cross-protection data to the U.S. FDA. GlaxoSmithKline recently submitted an application to the FDA for its investigational cervical cancer vaccine, Cervarix, which included data on HPV types 16, 18, 31 and 45.