RotarixTreatment for Prevention of Rotavirus Gastroenteritis
Update: Rotarix Now FDA Approved - April 3, 2008
GlaxoSmithKline's Application for Rotarix is Accepted for Review by the FDA
If Approved, New Candidate Vaccine Could Offer Completion of the Rotavirus Vaccination Series by Four Months of Age
PHILADELPHIA, August 14, 2007 /PRNewswire-FirstCall/ -- GlaxoSmithKline today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for Rotarix, an oral candidate vaccine for infants to prevent rotavirus gastroenteritis. Severe, dehydrating gastroenteritis occurs primarily among children aged three to 35 months. Of children hospitalized with rotavirus, approximately 17 percent are younger than six months old. If approved, the GSK candidate vaccine could offer completion of the rotavirus vaccination series by four months of age. The rotavirus candidate vaccine is a live- attenuated vaccine derived from the most common human rotavirus strain. Published data show that immunity resulting from natural human rotavirus infection provides significant protection against moderate to severe disease, regardless of rotavirus strain.
The BLA for the GSK rotavirus candidate vaccine is based on one of the largest clinical development plans undertaken by a vaccine manufacturer and includes data from nearly 75,000 infants. These clinical trials were conducted in the Americas, Europe, Asia and Africa and reflect an ethnically diverse population.
"This vaccine, which is designed to protect in a manner similar to natural human infection, could make a considerable contribution in protecting very young infants from rotavirus disease, a significant burden on families and the healthcare system in the U.S.," said Barbara Howe, M.D., Vice President, North American Vaccine Development, GlaxoSmithKline. "We also believe it is important to immunize infants against rotavirus as early as possible."
The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) recommend that infants receive routine vaccination against rotavirus to prevent rotavirus gastroenteritis with the vaccine currently licensed by the FDA at two, four, and six months of age.
The GSK rotavirus candidate vaccine is a live-attenuated oral rotavirus vaccine licensed in 99 countries around the world. The vaccine is designed to prevent rotavirus gastroenteritis by mimicking natural rotavirus infection. Studies have shown that natural rotavirus infection provides significant protection from moderate to severe disease, regardless of rotavirus strain. In the file under review by the FDA, it is proposed that the vaccine would be given in two oral doses beginning at six weeks of age and completed by 24 weeks of age, with a minimum four-week interval between the doses. If approved, the vaccine would typically be administered at the two and four month immunization visits.
Rotavirus infects virtually every child worldwide by age five and is the leading cause of severe acute gastroenteritis in infants and young children in the U.S. and worldwide. Severe diarrhea and dehydration occurs from as young as three months of age. In the U.S. each year, 2.7 million children younger than five years of age suffer from rotavirus disease, resulting in 410,000 clinic visits and up to 272,000 emergency room visits. In addition, between 55,000 and 70,000 children are hospitalized each year and 20-60 die.
GlaxoSmithKline: A Leader in Vaccines
GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research Triangle Park, NC, is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Biologicals (GSK Bio), one of the world's leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline's activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world -- an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination pediatric vaccines which protect the world's children from up to six diseases in one vaccine.
Cautionary statement regarding forward-looking statements
Under the safe harbor 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 2006.
1 Centers for Disease Control and Prevention. Prevention of Rotavirus Gastroenteritis Among Infants and Children. MMWR. 2006; 55(RR12); 1-13. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5512a1.htm. Accessed on May 31, 2007.
2 Green KY, et al. Homotypic and Heterotypic Epitope-Specific Antibody Responses in Adult and Infant Rotavirus Vaccinees: Implications for Vaccine Development. The Journal of Infectious Diseases. 1990;161:667-679.
3 GSK Clinical Trial Register. Available at: http://ctr.gsk.co.uk.
4 Centers for Disease Control and Prevention. Recommended Immunization Schedule for Ages 0-6 Years - United States 2007. Available at: http://www.aafp.org/online/etc/medialib/aafp_org/documents/clinical/immunizati on/childsched.Par.0001.File.dat/childsched.pdf. Accessed on July 22, 2007.
CONTACT: Liad Diamond, +1-919-483-2839, for GlaxoSmithKline
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Posted: August 2007
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