The FDA has granted Bexsero, a meningococcal group B vaccine, breakthrough therapy status.
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to a meningococcal group B vaccine, Novartis announced in a statement. The status is issued to fast track the development and review of new treatments for serious or life-threatening illnesses under FDA guidance.
Bexsero (rDNA, component, adsorbed) has already been approved in Europe, Canada, and Australia to help prevent meningitis B. Most recently, the United Kingdom recommended Bexsero for routine use in infants aged 2 months and older.
Students and staff at both Princeton University in New Jersey and the University of California, Santa Barbara received Bexsero following meningitis B outbreaks on their campuses. The US Centers for Disease Control and Prevention (CDC) has also issued a recommendation for the incoming freshman class at Princeton to receive the vaccine.
“The recent outbreaks on US university campuses have shown that meningitis B is unpredictable and can strike at any time with devastating consequences,” Andrin Oswald, Division Head of Novartis Vaccines, said in a press release. “A US license for Bexsero is the only sustainable solution to ensure timely responses to future outbreaks and to provide access to parents and physicians across the country. We will continue to work with the FDA to bring Bexsero to the US as soon as possible.”
Currently, meningitis A, C, Y, and W vaccines are available, though none exist for meningitis B, which is the most common cause of meningitis and septicemia.