September 10th, 2009
Ceravix Receives Commendatory Advice From FDA Advisory Committee
GlaxoSmithKline recently advised the public that the US FDA’s Vaccines and Related Biological Products Advisory Committee voted that Ceravix, the company’s cervical cancer vaccine, presented data that substantiates the efficacy and safety of the treatment.
With regards to the prevention of cervical pre-cancers and cervical cancer relevant to human papillomavirus (HPV) types 16 and 18, Ceravix proved to be both extremely impactful and satisfactory endured in girls and young women. In addition, the committee conversed on data which presented Ceravix’s efficacy while in contact with other cancer-causing viruses.
GlaxoSmithKline’s Vice President and Director of North American Vaccine Development, Barbara Howe, MD exclaims that their recent favorable FDA recommendations marks and “important step in cancer prevention for the millions of girls and young women at risk for cervical cancer … if approved, Ceravix will help provide protection against cervical cancer, a devastating disease that is responsible for thousands of deaths in US women each year.”
The FDA will review the committee’s commendatory advice during its concluding evaluation of the Biologics License Application for the candidate vaccine. If accepted, the FDA will finalize prescribing information.
General side effects displayed during clinical trials of the Ceravix vaccine were pain, swelling and redness, fatigue, headache, muscle ache and joint pain, gastrointestinal symptoms and fever. Major side effects were mainly similar between the groups who received Ceravix and the control groups.
March of 2009, marks the date when GSK presented their Phase III pivotal study concluding data, a trial study that was the biggest efficacy trial of a cervical cancer vaccine. The data included information harvested from clinical trials hosted in more than 30 countries which utilized 30,000 Ceravix participants, revealing an ethnically and racially varied female population. The study also covered a rigorous safety assessment applicable to girls and young women between the ages of 10-25.
