CervarixTreatment for Human Papillomavirus Prophylaxis
Update: Cervarix Now FDA Approved - October 16, 2009
FDA Advisory Committee Makes Favorable Recommendation for Cervarix
FDA Advisory Committee Makes Favorable Recommendation for Cervarix, GlaxoSmithKline's Candidate Cervical Cancer Vaccine
PHILADELPHIA, September 9, 2009 – GlaxoSmithKline announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that clinical data support both the efficacy and safety of Cervarix, the company’s candidate cervical cancer vaccine (12-1 and 11-1, respectively).
Cervarix was shown to be highly effective and well tolerated in girls and young women for the prevention of cervical pre-cancers and cervical cancer related to human papillomavirus (HPV) types 16 and 18, the two most common virus types that cause cervical cancer. The committee also discussed data demonstrating the efficacy of Cervarix against additional cancer-causing virus types.
"This is an important step in cancer prevention for the millions of girls and young women at risk for cervical cancer," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "If approved, Cervarix will help provide protection against cervical cancer, a devastating disease that is responsible for thousands of deaths in U.S. women each year."
The Committee’s favorable recommendation, although not binding, will be considered by the FDA in its final review of the Biologics License Application (BLA) for the candidate vaccine. If approved, the FDA will determine final prescribing information.
In clinical trials, the most common side effects after vaccination with Cervarix included pain, redness and swelling, fatigue, headache, joint and muscle aching, gastrointestinal symptoms and fever. Serious adverse events were generally comparable between the groups receiving Cervarix and the control groups.
In March 2009, GSK submitted final data from its Phase III pivotal study (HPV-008), the single largest efficacy trial of a cervical cancer vaccine to date. The file included data from clinical trials in more than 30 countries involving nearly 30,000 participants receiving Cervarix, which reflect an ethnically and racially diverse population and a broad range of women. It also included a thorough safety assessment relevant to 10-25 year old girls and young women.
GSK designed Cervarix with its ASO4 adjuvant system to deliver high and sustained levels of antibodies aimed at providing long-term protection against cancer-causing HPV types, although the exact level of antibodies that confer protection is not known. Protection has been shown through 6.4 years and ongoing clinical studies continue to assess duration of protection. ASO4 enhances the body’s immune response to the antigens contained in the vaccine. This response provides protection at the cervix, where natural antibody response to infection may not adequately protect against future infections with the same virus type.
To date, Cervarix has been approved in nearly 100 countries around the world, including the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan. Licensing applications have been submitted in more than 20 additional countries, including Japan and the United States. GSK also received World Health Organization (WHO) prequalification in July 2009.
Cervarix (Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant) is a registered trademark of the GlaxoSmithKline group of companies.
About Cervical Cancer
Women are at risk of HPV infection and cervical cancer throughout their sexually active lives. Approximately 100 types of HPV have been identified to date and, of these, approximately 15 virus types are known to cause cervical cancer. HPV types 16 and 18 are responsible for approximately 70 percent of cervical cancers globally, with types 31, 33 and 45 among the next most common cancer-causing HPV strains. Infection with cancer-causing virus types can lead to abnormal Pap smears, cervical pre-cancers and cervical cancer. Treatment of cervical pre-cancers and cancer at any stage may require invasive procedures that in some cases may damage a woman’s cervix and may potentially impact her ability to have a child.
The American Cancer Society estimates that in 2009, in the U.S. approximately 11,000 women will be diagnosed with cervical cancer and 4,000 women will die from the disease. Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and 280,000 women will die from it each year.
GSK Biologicals, GlaxoSmithKline’s vaccines business, is one of the world’s leading vaccine companies and a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Biologicals has 13 manufacturing sites strategically positioned around the globe. In 2008 GSK Biologicals distributed 1.1 billion doses of vaccines to 176 countries in both the developed and the developing world – an average of 3 million doses a day.
Through its accomplished and dedicated workforce, GSK Biologicals applies its expertise to discover innovative vaccines that contribute to the health and well-being of people of all generations around the world.
One of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2008.
Posted: September 2009
- FDA approves Cervarix, GlaxoSmithKline's cervical cancer vaccine - October 16, 2009
- Cervarix U.S. Regulatory Update - March 30, 2009
- GlaxoSmithKline Responds to FDA on Cervarix and Plans to Submit Final Study Data for Approval - June 30, 2008
- GlaxoSmithKline Receives FDA 'Complete Response' Letter for Cervarix Cervical Cancer Vaccine - December 17, 2007
- GlaxoSmithKline Submits Biologics License Application to U.S. Food and Drug Administration for Cervarix - March 29, 2007