Novartis meningitis B vaccine Bexsero® receives FDA Breakthrough Therapy designation in the US

Novartis International AG / Novartis meningitis B vaccine Bexsero® receives FDA Breakthrough Therapy designation in the US . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• The designation highlights the potential of Bexsero to meet the urgent need for a licensed vaccine in the US against unpredictable and devastating meningitis B[1]

Bexsero, already approved in Europe, Canada and Australia, is the only broad coverage meningitis B vaccine that can be used from two months of age[2],[3],[4],[5]

Bexsero was recently provided to two US universities under an Investigational New Drug (IND) designation; Novartis plans to file in the US as early as Q2 2014[6],[7]

Basel, April 7, 2014 - Novartis announced today that Bexsero^® (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) has received a Breakthrough Therapy designation from the United States Food and Drug Administration (FDA). Bexsero is already approved in Europe, Canada and Australia to help protect against invasive meningococcal disease caused by serogroup B (meningitis B)[2],[3],[4],[5]. 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[8],[9],[10].

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[11].

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[6],[7],[12]. 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."