GlaxoSmithKline (NYSE: GSK) announced today that the company has
submitted a Biologics License Application (BLA) for CERVARIX® (human
papillomavirus vaccine, AS04 adjuvant-adsorbed), its cervical cancer
candidate vaccine, to the U.S. Food and Drug Administration (FDA). For this candidate vaccine,
GSK selected a novel proprietary adjuvant system called AS04, intended
to enhance immune response and increase duration of protection.
Todays filing is an important milestone for
GSK and reflects our commitment to help prevent cervical cancer, the
second most common cancer among younger women, said JP Garnier, CEO of
GlaxoSmithKline, one of the worlds leading vaccine manufacturers. We
believe that the best possible protection against cervical cancer will
include routine screening together with a vaccine designed to provide
targeted, durable protection against the most common cancer-causing
The BLA for the GSK cervical cancer candidate
vaccine includes data from clinical trials in almost 30,000 females 10
to 55 years of age and reflects an ethnically diverse population. The
submission also contains data from the largest Phase III cervical
cancer vaccine efficacy trial to date, which was conducted around the
world in more than 18,000 females 15 to 25 years of age.
We are pleased to submit this file to the FDA,
said Barbara Howe, MD, Vice President and Director, North American
Vaccine Development Organization, at GlaxoSmithKline. It includes a
considerable amount of data for virus types 16 and 18 that cause 70
percent of cervical cancer cases worldwide, as well as data for other
virus types that can lead to cervical cancer. We look forward to
presenting study results in the coming months.
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.
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