April 18, 2007
Merck applies for expanded Gardasil use, Glaxo says Cervarix offers protection for over 5 years
Merck said yesterday it has applied with the FDA for expanded approval of its Gardasil vaccine to help prevent vaginal and vulvar cancers.
Gardasil protects patients against four types of the sexually transmitted human papillomavirus. Two types of the virus are responsible for about 70% of cervical cancer cases, while the other two types are responsible for about 90% of genital wart cases.
However, all four types of the HPV virus account for 35% to 50% of all low-grade cervical, vulvar and vaginal lesions, Merck said.
Merck expects the FDA to determine whether it will accept Merck’s application for review within the next 60 days. If the agency reviews the application, a decision could come within 10 months of the filing date. Gardasil received its first approval for cervical cancer in June 2006.
Meanwhile, GlaxoSmithKline said yesterday that its developmental cervical cancer vaccine Cervarix has been found to prevent women from developing pre-cancerous lesions caused by the two main cancer-causing viruses for five-and-a-half years.
Glaxo claimed the results demonstrate the longest duration of protection seen in any cervical cancer vaccine trial reported to date.
In new data presented at the American Association for Cancer Research, Cervarix showed 68% vaccine efficacy against pre-cancerous lesions and 38% efficacy against abnormal Pap smears, regardless of the type of cancer-causing virus detected, Glaxo said
The data also provided further evidence of cross-protection against infection with the less common cancer causing viruses that extended for up to 5.5 years.
Cervarix is waiting for marketing approval in US. If approved and launched, it will compete against Gardasil.
Gardasil has gained an early advantage as the only cervical cancer vaccine on the market.
Analysts have given Gardasil the edge but GlaxoSmithKline has countered that Cervarix is more powerful.
The drugmaker is funding an unusual head-to-head study to try to prove that Cervarix is more potent than Gardasil. Results of the study are anticipated by January 2008.