| Novartis receives approval in the European Union for Menveo |
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18/03/2010 11:33 (695 Day 20:50 minutes ago) | |||||
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The FINANCIAL -- Novartis announced on March 18 that the European Commission (EC) granted a Marketing Authorization for Menveo (Meningococcal Group A, C, W135 and Y conjugate vaccine) in all 27 European member states.
"Menveo is indicated for the active immunization of adolescents (from 11 years of age) and adults at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y, to prevent invasive disease. Menveo is the first conjugate vaccine commercially available in Europe that helps protect against four major groups of meningococcal disease. Novartis intends to submit additional data to the European Medicines Agency to support the use of Menveo in other age groups," Novartis says.
Meningococcal infection is a leading cause of bacterial meningitis - an infection of the membrane around the brain and spinal cord - and sepsis - a bloodstream infection[4],[5]. Meningococcal disease progresses rapidly and can lead to death within 24-48 hours of the first symptoms[6]. Of those who survive, as many as one in five will suffer life-long complications such as brain damage, learning disabilities, hearing loss and limb loss[4].
"Marketing approval for Menveo for people ages 11 and older is the culmination of 10 years of dedicated effort by Novartis Vaccines to provide a vaccine that can help protect against meningococcal disease," said Andrin Oswald, Division Head of Novartis Vaccines and Diagnostics. "Our priority is to advance the fight against meningitis through innovative vaccines that help save lives."
The majority of all meningococcal disease cases around the world can be attributed to five main groups - called serogroups - of the bacteria that cause meningococcal disease, Neisseria meningitidis[2]. Importantly, dominant groups of meningococcal disease can vary by country and region, and change over time, making it an even more unpredictable disease[2]. The most effective way to prevent this deadly disease is through the use of a vaccine that offers protection against as many bacterial groups as possible[1].
Adolescents and young adults are at increased risk of contracting meningococcal disease, often because they start to encounter new situations and undergo changes in their lifestyles[5],[7]. Other groups at increased risk of contracting meningococcal disease include travelers, military personnel and Muslim pilgrims traveling to the Hajj or Umrah[6].
Menveo was developed using conjugate technology, which was pioneered by Novartis Vaccines in the development of its meningococcal group C conjugate vaccine, Menjugate. A conjugate vaccine is developed by attaching a polysaccharide antigen - the key component of a vaccine that prompts the body to respond to infection - to a carrier protein in order to enhance the body's immune response to the vaccine[7].
When utilized in a national immunization program, conjugate vaccines (such as those designed to help protect against Hib, pneumococcal and meningococcal group C disease) have reduced the number of people (both vaccinated and unvaccinated) who carry the bacteria that cause the disease[7]. Novartis is currently studying the long-term safety and immunogenicity of Menveo, and is considering clinical studies on carriage.
Menveo has been administered to more than 18,500 people and is currently in multiple Phase III clinical studies in infants and toddlers worldwide[8]. The U.S. Food and Drug Administration (FDA) recently approved Menveo for use in 11-55 year olds.
Study Details
Marketing Authorization was based on data from a pivotal Phase III clinical trial and a non-inferiority study. In the non-inferiority study, immune response was assessed among adolescents 11-17 years of age. Menveo was shown to be non-inferior to a quadrivalent meningococcal polysaccharide vaccine (ACWY-PS) for all four meningococcal groups contained in the vaccine[3]. At one year after vaccination, a higher proportion of adolescents who received Menveo had maintained a protective immune response against three of the four meningococcal groups (groups C, W135 and Y) than those who received ACWY-PS[3]. Further, when evaluated in adults 56-65 years of age, Menveo was shown to be non-inferior to ACWY-PS in all four meningococcal groups contained in the vaccine and statistically superior for groups A and Y[3]. The clinical significance of these findings is unknown.
Achieving and maintaining an immune response in adolescents is considered important because they are particularly susceptible to meningococcal disease and are more likely to carry the bacteria than other age groups[9]. In addition, adolescents and young adults have relatively high death rates from meningococcal infection[10]. A study in the United States found that nearly a quarter of meningococcal infections in 15- through 24-year-olds were fatal[10].
"Meningitis often develops without warning, and progresses rapidly, making it a particularly dangerous disease[6],[11]," said Chris Head, Chief Executive of the Meningitis Research Foundation, UK. "Awareness of symptoms, understanding treatment and, above all, prevention with a vaccine that helps to protect against multiple groups of bacteria will help save lives and prevent devastating, lifelong after-effects."
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