Novartis Vaccines announced that Menveo (Meningococcal Group A, C, W-135 and Y-CRM Conjugate Vaccine) has received a Positive Opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). The investigational conjugate vaccine is recommended for 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 designed to help protect against four of the five major groups of meningococcal bacteria, which are leading causes of bacterial meningitis an infection of the membrane around the brain and spinal cord and sepsis a bloodstream infection.
The CHMP recommendation serves as the basis for a European Commission licensing Decision. The CHMP is recommending that the European Commission grant Marketing Authorization for Menveo in all 27 European Union (EU) countries, which is expected during the first quarter of 2010. Regulatory review for Menveo by the US Food and Drug Administration is ongoing.
Upon licensure, Menveo is expected to be the first conjugate vaccine to be commercially available in Europe to help protect against four major groups of meningococcal bacteria. Meningococcal disease is a sudden, life-threatening illness that can lead to death within 24 to 48 hours of the first symptoms. Of those who survive, as many as one in five will suffer life-long after effects, such as brain damage, learning disabilities, hearing loss and limb loss.
The Committees positive recommendation of Menveo is a significant advance in the fight against meningococcal disease,said professor Ray Borrow who heads the Health Protection Agency's Vaccine Evaluation Unit in the UK. Five groups of meningococcal bacteria cause the majority of meningococcal disease cases around the world. Since it is impossible to predict which meningococcal bacterial group one might come into contact with, a vaccine that offers effective protection against four of the groups should be extremely effective in preventing and controlling the disease. It is a welcome development.
This is an important milestone toward our vision to eradicate this devastating, deadly and unpredictable disease, said Andrin Oswald, CEO of Novartis Vaccines and Diagnostics. We are confident that broad coverage with Menveo will eventually be available to all age groups.
Menveo was developed using conjugate technology, which was also used to develop Novartis Vaccines 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. 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.
Adolescents are particularly susceptible to meningococcal disease and are more likely to carry the bacteria than other age groups. In addition, adolescents and young adults have relatively high death rates from meningococcal infection. A study in the United States found that nearly a quarter of meningococcal infections in 15- through 24-year-olds were fatal.
Menveo has been administered to more than 18,500 people and is currently in multiple Phase III clinical studies in infants and toddlers worldwide.