News Feature | April 8, 2014

Novartis' Bexsero For Meningitis Receives FDA Breakthrough Status

By Estel Grace Masangkay

Novartis announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its meningitis B vaccine Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]). The latest Breakthrough designation is Novartis’ fourth in the development of innovative therapies and vaccines.

Andrin Oswald, Division Head of Novartis Vaccines, said, “The recent outbreaks on U.S. university campuses have shown that meningitis B is unpredictable and can strike at any time with devastating consequences. A U.S. 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 U.S. as soon as possible.”

The designation follows the positive recommendation of Joint Committee on Vaccination and Immunization (JCVI) in the UK to include Bexsero in the country’s National Immunization Program (NIP) for routine use in infants from two months of age. Under an FDA Investigational New Drug (IND) designation, Novartis has provided almost 30,000 doses of the drug to Princeton University and the University of California Santa Barbara (UCSB) students and staff following meningitis B outbreaks on the campuses.

Meningitis B is a rare and aggressive disease that can cause serious life-long disability and even death within 24 hours of onset. This makes vaccination the weapon of choice against the disease as its speed leaves little time for medical intervention. About one in ten will die in spite of treatment. Of those who survive, one in five will be afflicted with life-long disabilities such as brain damage, loss of limb, or loss of hearing.

Bexsero is approved in Europe, Canada, and Australia to help protect against invasive meningococcal disease caused by serogroup B. The company said it intends to file for U.S. licensure as early as the second quarter of 2014, depending on guidance from the FDA.