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news.Novartis announced that the US Food and Drug Administration (FDA) has granted accelerated approval of Bexsero (Meningococcal Group B Vaccine [recombinant, adsorbed]) for active immunization to prevent invasive meningococcal disease caused by serogroup B (also known as meningitis B) in adolescents and young adults from 10 years through 25 years of age.
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Bexsero is the only meningitis B vaccine approved in the US with a two-dose regimen and a flexible dosing schedule[1]. As part of the accelerated approval process, Novartis will complete its ongoing studies to confirm the effectiveness of Bexsero against diverse serogroup B strains.
"While rare, meningitis B is a devastating disease that can hit anyone anytime, especially teenagers and children," said Andrin Oswald, Division Head, Novartis Vaccines. "This approval is an important milestone towards our goal of helping to prevent any further loss of life."
In Phase II and Phase III studies, Bexsero demonstrated a protective immune response in adolescents and young adults after two doses. Bexsero also offers a flexible dosing schedule, with the first and second doses administered at least one month apart.
"As someone who contracted meningitis during college, I am hopeful that young adults across the country will soon have routine access to meningitis B vaccines," said Jamie Schanbaum, 25-year-old founder of the meningitis advocacy organization The J.A.M.I.E. Group.
"There is no reason that young people in the US should be in danger of a vaccine-preventable disease as devastating as meningitis."
The tolerability profile of Bexsero was also demonstrated as part of a US Centers for Disease Control and Prevention (CDC)-sponsored clinical trial conducted in more than 15,000 individuals at Princeton University and the University of California, Santa Barbara (UCSB) during meningitis B outbreaks on these college campuses. The safety data from the CDC clinical trial are consistent with results observed in previous studies.
Invasive meningococcal disease, which may present as bacterial meningitis, can be easily misdiagnosed and while rare, it can have serious consequences including lifelong disability and sometimes death within 24 hours of symptom onset.
Neisseria meningitidis B has become the most prevalent of the serogroups that cause meningococcal disease in the US, accounting for 33 percent of all reported cases in 2013. Even with antibiotic treatment, as many as 10 percent of people infected with meningococcal disease will die and almost one in five survivors will suffer long-term disability.
Adolescents and young adults are at an increased risk of contracting meningococcal disease due to common lifestyle habits, such as living in college dormitories.
In January 2013, Bexsero was approved by the European Commission for use in individuals from 2 months of age and older, making it the first broad coverage vaccine to receive a regulatory approval to help protect against meningitis B.
The US approval of Bexsero underscores the unique leadership position of Novartis in the global fight against meningococcal disease. Together, Bexsero and Menveo (Meningococcal Group A, C, W-135 and Y conjugate vaccine) help to protect against all five main serogroups of meningococcal bacteria (A, C, W-135, Y and now B) that cause the majority of cases in the US and around the world.