FRIDAY, SEPTEMBER 30, 2016

Novartis submits application to FDA for Bexsero meningitis vaccine

Novartis announced the submission on Tuesday of a Biologic License Application for its Bexsero meningitis B vaccine to the U.S. Food and Drug Administration.

Bexsero, which has already been approved by 34 countries, is targeted toward adolescents and young adults from 10-25 years of age and is the first broad coverage vaccine to protect against meningitis.

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

Novartis recently provided approximately 30,000 doses of Bexsero to students and staff at the University of California, Santa Barbara and Princeton University following meningitis B outbreaks on their campuses. The FDA allowed the distribution of Bexsero under an Investigational New Drug designation, and the Centers for Disease Control and Prevention recommended that the incoming class in the at-risk group at Princeton receive Bexsero.

The license application for Bexsero begins a rolling submission process to the FDA, following its designation as a Breakthrough Therapy in April of this year.