GlaxoSmithKline (NYSE:GSK) has recently submitted a Biologics License Application (BLA) for CERVARIX® (human papillomavirus vaccine, AS04 adjuvant-adsorbed) to the USFDA.
CERVARIX® is GSK’s candidate vaccine for cervical cancer, which when approved will be indicated for the prevention of cervical cancer and precancerous lesions associated with the most common cancer-causing human papillomavirus (HPV) types.
The GSK cervical cancer candidate vaccine is formulated with a proprietary adjuvant system called AS04, containing aluminum hydroxide and monophosphoryl lipid A (MPL®).
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.
The submitted BLA included clinical data derived from 30,000 ethnically-diversed females aged 10 to 55 and a large phase III cervical cancer efficacy data.
Find more details from the press release.
[photo credit: GlaxoSmithKline]
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