The United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Novartis' Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]).

Bexsero is already approved in Europe, Canada and Australia to help protect against invasive meningococcal disease caused by serogroup B (meningitis B). Novartis plans to file for US licensure of Bexsero as early as Q2 2014; exact timing will depend on guidance from the FDA. This is the fourth Breakthrough Therapy designation for Novartis, underscoring leadership in developing innovative therapies and vaccines.

This announcement comes on the heels of a landmark decision from regulators in the UK, where the Joint Committee on Vaccination and Immunisation (JCVI) recommended the inclusion of Bexsero in the country's National Immunisation Programme (NIP) for routine use in infants from two months of age.

In the last four months, Novartis has provided nearly 30,000 doses of Bexsero to students and staff at Princeton University and the University of California Santa Barbara (UCSB) following meningitis B outbreaks on their campuses under an Investigational New Drug (IND) designation from the FDA. Further, the US Centers for Disease Control and Prevention (CDC) have recommended including the incoming freshman class at Princeton University in the at-risk group to receive Bexsero.

"The recent outbreaks on US university campuses have shown that meningitis B is unpredictable and can strike at any time with devastating consequences," said Andrin Oswald, Division Head, Novartis Vaccines. "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."

According to the FDA, Breakthrough Therapy designation is intended to expedite the development and review of new medicines that treat serious or life-threatening conditions. The designation includes all of the fast track programme features, as well as more intensive FDA guidance. Meningitis B is the leading cause of bacterial meningitis and septicemia in the developed world. With vaccines currently available in the US to help prevent the other four most common serogroups that cause meningococcal disease (A, C, Y and W), a licensed vaccine offering protection against serogroup B remains an unmet public health need in the US. Today's announcement also highlights Novartis' leadership in developing innovative vaccines against meningococcal disease, as the only company with licensed vaccines for all five main serogroups that together cause the majority of cases in the world.

Meningitis B is a rare but aggressive disease that can kill or cause serious life-long disability within 24 hours of onset. Because initial symptoms are often unspecific and flu-like, it can be difficult for even a healthcare professional to diagnose the disease in its early stages. About one in 10 of those with the disease will die despite appropriate treatment and of those who do survive, one in five will suffer from devastating, life-long disabilities such as brain damage, hearing loss or limb loss. Vaccination is therefore the best defense against the disease which leaves little time for intervention.