Novartis announced its submission of a license application for Bexsero to the U.S. Food and Drug Administration. Bexsero helps protect people from invasive meningococcal disease from serogroup B or meningitis B common in young adults aged between 10 and 25 years.
The submission comes after the Breakthrough Therapy designation last April 2014, which highlights the need for a licensed serogroup B vaccine in the United States. Though meningitis B is rare, it is an aggressive disease that kills or causes life-long disability within only 24 hours from contact, often starting with flu-like symptoms.
Bexsero is currently approved in 34 countries and in response to recent outbreaks, was also allowed to two universities in the United States under an Investigational New Drug designation. Bexsero is the first full coverage vaccine that helps protect from meningitis B. It is approved in Europe, Australia and Canada among others. Since it was launched in 2013, more than 500,000 doses have already been distributed around the world.
"The recent outbreaks on U.S. university campuses have shown that meningitis B is unpredictable and can strike at any time with devastating consequences," Novartis Vaccines Division Head Andrin Oswald said. "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."
Early in 2014, Novartis provided almost 30,000 Boxsero doses to University of California Santa Barbara and Princeton University staff and students after meningitis B outbreaks around the campuses. The U.S. Centers for Disease Control and Prevention (CDC) recommended incoming freshman students at Princeton to be included in the at-risk group that received Bexsero.
Bexsero comes from 20 years of extensive research and according to Novartis, the submission is a step closer in ensuring that American families are protected from losing a loved one due to a vaccine-preventable disease. Novartis said it is a testament to its leadership in preventing devastating diseases.
Around one in 10 of people with meningitis B will die in spite of appropriate treatment and one in five survivors will suffer from life-long disabilities including hearing loss, limb loss or brain damage. Meningitis B is difficult to diagnose in its early stage because symptoms are flu-like and unspecific. For a disease that leaves only little intervention time, vaccination can be the best defense.
