Wyeth Provides Regulatory Update on Prevnar 13* in the United States
- Category: Vaccines
- Published on Wednesday, 12 August 2009 03:00
- Hits: 1319
FDA extends review time by 90 days
COLLEGEVILLE, PA, USA | August 11, 2009 | Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced it received notice that the action date for the U.S. Food and Drug Administration's (FDA) review of the Biologics License Application (BLA) for Prevnar 13(TM), (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) has been extended from September 30, 2009, to December 30, 2009. In response to an FDA request, Wyeth submitted additional analytical method validation and specification information relating to physical/chemical properties of the product in late July. FDA considered this to be a major amendment and, as a result, they have elected to extend the review cycle for Prevnar 13 by 90 days. Prevnar 13 is under review for active immunization of infants and young children for the prevention of invasive disease and otitis media caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes.
"This is a significant application that is under priority review and we are working closely with the FDA on the review, including conduct of the pre-approval inspections," says Emilio Emini, Ph.D., executive vice president, Vaccine Research and Development, Wyeth Pharmaceuticals. "Priority review designation is given to products that, if approved, would be a significant therapeutic or public health advance. We continue to believe that our application supports the approval of Prevnar 13."
Prevnar 13(TM) is based on the scientific foundation of Prevnar (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the standard in pneumococcal disease prevention for infants and young children. It contains the seven serotypes in Prevnar (4, 6B, 9V, 14, 18C, 19F and 23F), plus six additional serotypes (1, 3, 5, 6A, 7F and 19A) responsible for the greatest remaining burden of invasive disease. Prevnar has been available in the U.S. for more than nine years. It is currently available in 95 countries and more than 235 million doses have been distributed worldwide.
The Prevnar 13 submission is based on a clinical trial program of 13 core Phase 3 studies involving more than 7,000 infants and young children. To date, the company has submitted regulatory applications for Prevnar 13 in more than 50 countries spanning six continents, with filings in additional countries planned. In July, Prevenar 13*, as it is known outside the U.S., was approved in Chile for use in infants and young children.
About Pneumococcal Disease
Pneumococcal disease is complex and describes a group of illnesses all caused by the bacterium Streptococcus pneumoniae. Pneumococcal disease is the leading cause of vaccine-preventable death worldwide in children younger than 5 years of age and is estimated to cause up to one million deaths worldwide in children each year.
Pneumococcal disease affects both children and adults, and includes invasive infections such as bacteremia/sepsis and meningitis, as well as pneumonia and otitis media.
Important Safety Information for Prevnar 13*
In clinical studies, the most commonly reported adverse events in children were injection site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep. Risks are associated with all vaccines, including Prevnar 13. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. As with any vaccine, Prevnar 13 may not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes.
Indication for Prevnar
Prevnar is indicated for active immunization of infants and toddlers against serious invasive disease caused by Streptococcus pneumoniae, including bacteremia (bloodstream infection) and meningitis (infection of the membranes surrounding the brain and spinal cord) caused by the seven serotypes in the vaccine. The seven serotypes (strains) of S. pneumoniae included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F) are the strains that most commonly cause these serious diseases in children. The routine schedule is 2, 4, 6, and 12 to 15 months of age.
Prevnar is also indicated for immunization of infants and toddlers against otitis media (ear infections) caused by the seven serotypes in the vaccine. Protection against ear infections is expected to be less than that for invasive disease.
As with any vaccine, Prevnar may not protect all individuals receiving the vaccine from serious invasive disease caused by S. pneumoniae. This vaccine should not be used for treatment of active infection.
Important Safety Information for Prevnar
Ask your child's health care provider about the risks and benefits of Prevnar and if Prevnar is right for your child.
In clinical studies, the most frequently reported adverse events included injection site reactions, fever (greater than or equal to 38 degrees C/100.4 degrees F), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, and rash.
Risks are associated with all vaccines, including Prevnar . Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. Prevnar does not protect 100% of children vaccinated. Immunization with Prevnar does not substitute for routine diphtheria immunization.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
SOURCE: Wyeth Pharmaceuticals