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news.GlaxoSmithKline has submitted a biologics license application for Cervarix, its cervical cancer candidate vaccine, to the FDA.
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If licensed, the vaccine will be indicated for the prevention of cervical cancer and precancerous lesions associated with the most common cancer-causing human papillomavirus types.
For this candidate vaccine, GSK selected an adjuvant system called AS04, intended to enhance immune response and increase duration of protection. Published data have shown that the GSK cervical cancer candidate vaccine formulated with AS04 provides a stronger and longer lasting immune response compared to the same GSK vaccine composition formulated with a traditional aluminum hydroxide adjuvant.
“We are pleased to submit this file to the FDA,” said Barbara Howe, vice president and director of North American Vaccine Development Organization at GlaxoSmithKline. “It includes a considerable amount of data for virus types 16 and 18 that cause 70% of cervical cancer cases worldwide, as well as data for other virus types that can lead to cervical cancer.”
In addition to the application submitted for Cervarix with thee FDA, GSK has submitted a marketing authorization application to the European Medicines Agency, Australia, Canada, and major countries in Asia and Latin America.