Novartis submits application for FDA approval of meningitis B vaccine

Already granted ‘Breakthrough Therapy’ status in April, Novartis aims for its meningitis B vaccine candidate to meet the need of a licensed vaccine for the rare but deadly disease.

by John Tyburski

Copyright © Daily Digest News, KPR Media, LLC. All rights reserved.

First published at Daily Digest News on June 19, 2014

Novartis International AG, the large, Swiss pharmaceutical company based in Basel, Switzerland, announced on Tuesday that it submitted an application for Bexsero® to be approved by the U.S. Food and Drug Administration (FDA) as a vaccine against meningitis serogroup B. Bexsero is already approved as such in 34 countries and was recently made available at two U.S. universities as an Investigational New Drug during meningitis B outbreaks.

Four vaccines for meningococcal illness currently exist, but none cover serogroup B, a rare but aggressive illness that can kill or lead to life-long disability. The devastating effects of meningitis B can occur within 24 hours of the onset of illness, which presents with flu-like symptoms, making it difficult to accurately diagnosis unless during an epidemic. Bacterial meningitis is caused by the bacterium Neisseria meningitidis infecting the meninges, or protective coverings of the brain and spinal cord.

“Bexsero is the result of 20 years of groundbreaking research and a testament to our leadership in preventing rare but devastating diseases,” said Andrin Oswald, Division Head, Novartis Vaccines. “With today’s submission, we are one step closer to ensuring that no family in the US has to endure the loss of a loved one from vaccine-preventable meningitis.”

Meanwhile, the U.S.-based multinational pharmaceutical corporation Pfizer also announced Tuesday that it has requested FDA approval for its candidate meningitis serogroup B vaccine candidate called bivalent rLP2086. Pfizer’s candidate vaccine was also granted Breakthrough Therapy Designation by the FDA earlier this year.

“The BLA submission for bivalent rLP2086 marks an important step toward our goal of helping to protect adolescents and young adults against this difficult to diagnose and often deadly disease,” said Dr. Emilio Emini, Senior Vice President of Vaccine Research and Development for Pfizer Inc. “There is an urgent public health need to help prevent meningococcal B disease through vaccination, and we will continue to work closely with the FDA in our efforts to advance our vaccine candidate.”