Navigation Links
GlaxoSmithKline Responds to FDA on CERVARIX(R) and Plans to Submit Final Study Data for Approval
Date:6/30/2008

LONDON and PHILADELPHIA, June 30 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) today provided the following update regarding its application to the U.S. Food and Drug Administration (FDA) for approval of CERVARIX(R), its vaccine to prevent cervical cancer.

GSK has submitted its response to questions raised by the FDA in their Complete Response Letter, received in December, 2007. In addition, given that final data from GSK's Phase III pivotal efficacy study, HPV-008, are expected to be available later this year, GSK has decided to augment its application for approval with these data to ensure they are included in the U.S. label. GSK anticipates submitting these data in the first half of 2009. The timing depends on reaching a certain number of cases in order to conduct the final analysis. An FDA action on the application is expected to take up to six months following this submission. Interim data from this study were filed in the original application for the vaccine in March, 2007. The company does not expect that new clinical studies will be required for approval.

"Study 008 is a key study that will be completing later this year, and we expect the final results will strengthen the U.S. label for CERVARIX(R)," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "We continue to have positive and productive discussions with the FDA and remain confident in the vaccine's safety and efficacy profile. We look forward to bringing this important new cervical cancer vaccine to girls and women in the U.S."

To date, GSK's cervical cancer vaccine has been approved in 67 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines. Licensing applications have been submitted in more than 35 additional countries including Japan. GSK also submitted the vaccine to the World Health Organization (WHO) for prequalification in September 2007.

Notes to Editors

Burden of Cervical Cancer

Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and over 280,000 women will die from it each year.(1) In the United States, after breast cancer, cervical cancer is the second leading cause of cancer death in women ages 20 to 39.(2)

About GlaxoSmithKline

GlaxoSmithKline -- 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 company information, please visit http://www.gsk.com/media.

GlaxoSmithKline Biologicals (GSK Biologicals) is a leading global vaccine manufacturer committed to preventing disease in people of all ages with innovative vaccines and delivery systems. The division, headquartered in Belgium, is active in vaccine research, development and production with more than 30 vaccines currently available globally and 20 more in development. In 2007 GSK Biologicals distributed 1.1 billion doses of vaccines -- an average of 3 million doses a day.

CERVARIX(R) is a registered trademark of the GlaxoSmithKline group of companies.

GSK cautionary statement regarding forward-looking statements

Under the safe harbour provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, 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 the Group's operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report on Form 20-F for 2007.

References:

1. World Health Organization. Initiative for Vaccine Research. http://www.who.int/vaccine_research/diseases/hpv/en/ Accessed on May 2, 2007.

2. Jemal A, Murray T, Ward E, Sammuels A et al. Cancer Statistics, 2005. Cancer Journal for Clinicians 2005; 55; 10-30


'/>"/>
SOURCE GlaxoSmithKline
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. GlaxoSmithKline Collaborates with National Cancer Institute to Make Large Body of Cancer Cell Genomic Data Available to All Cancer Researchers
2. GlaxoSmithKline Announces New Drug Application and Phase III Results for Rezonic(TM)/Zunrisa(TM) (Casopitant)
3. GlaxoSmithKline Reports Further Progress of Oncology Portfolio
4. Paul Capital Healthcare Purchases Additional Royalty Interest in GlaxoSmithKlines Rotarix(R)
5. GlaxoSmithKline and Theravance Announce Start of Large Phase 2B ICS and LABA Studies for Asthma in the Horizon Program
6. Coley Pharmaceutical Group Receives $3.0 Million Milestone Payment from GlaxoSmithKline
7. New Data Show That GlaxoSmithKlines Rotarix(R) Could Be Given With Other Routine Infant Vaccines in the U.S.
8. GlaxoSmithKline Accelerates Review of Exelixis XL880
9. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
10. Roche responds to announcement of IDEAL hepatitis C trial results
11. Solvay Pharmaceuticals, Inc. Responds to Advisory Committee Recommendation for Further Study of Tedisamil to Treat Atrial Fibrillation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/27/2017)... AMSTERDAM , Feb. 27, 2017   ... AEX: PHIA), a global leader in health technology, ... and Drug Administration (FDA) to market its ElastQ ... EPIQ family of ultrasound systems. ElastQ Imaging enables ... stiffness, which is essential for the diagnosis of ...
(Date:2/27/2017)...  Infinity Pharmaceuticals, Inc. (NASDAQ: INFI ) ... th Annual Healthcare Conference on Monday, March 6, ... MA. A live webcast of Infinity,s presentation ... website at www.infi.com , and will be available ... Infinity,Infinity is an innovative biopharmaceutical company dedicated to advancing ...
(Date:2/27/2017)... A recent research report published by Grand View Research, ... to reach a value of $55.8 billion by 2025. Earlier in ... have legalized marijuana for medical uses. In 2016, states such as ... North Dakota , Ohio and ... in medical applications such as chemotherapies and pain management. The growing ...
Breaking Medicine Technology:
(Date:2/28/2017)... ... February 28, 2017 , ... TruClinic Inc. announced ... company based in New York. , “Ensuring an intuitive, user-friendly patient experience is ... Those two fundamental reasons are the reasons this acquisition is an obvious one,” ...
(Date:2/28/2017)... ... February 28, 2017 , ... ... has challenges as they transition from military to civilian life. Body image dissatisfaction ... million who experience poorer health and greater occurrence of chronic mental health conditions ...
(Date:2/27/2017)... ... 27, 2017 , ... Bo Chen, PhD is the recipient of the 2017 ... during the Plenary Session at ASLMS 2017, the Annual Conference of the American Society ... April 5-9, 2017. , During the Plenary Session on April 7, Dr. Chen ...
(Date:2/27/2017)... ... 2017 , ... Hotze Health & Wellness Center (HHWC), a ... New Guest Director. , Brandl is a dynamic and influential executive leader ... his professional career at Omnium Worldwide, now known as West Corporation, and handled ...
(Date:2/27/2017)... , ... February 27, 2017 , ... ... Shamanic Healing and Spiritual Awakening, is happy to announce her “Spring Rejuvenation ... and body, these individual customized retreats offer the winter-weary soul an excellent opportunity ...
Breaking Medicine News(10 mins):