Novartis receives approval in the European Union for Menveo
Novartis announced 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.
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. 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.
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.
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. 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. The U.S. Food and Drug Administration (FDA) recently approved Menveo for use in 11-55 year olds.
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