MONDAY, JUNE 25, 2018

Bexsero receives Breakthrough Therapy designation from FDA

Novartis announced on Monday that its meningococcal group B vaccine Bexsero received a Breakthrough Therapy designation from the U.S. Food and Drug Administration.

The vaccine is already approved for use in the United Kingdom, Canada and Australia, and was recently recommended for the U.K.'s National Immunisation Programme for use in infants as young as two months of age.

Novartis said it provided approximately 30,000 Bexsero vaccines to students and staff and Princeton University and the University California Santa Barbara in response to meningitis B outbreaks. The vaccine was recommended by the U.S. Centers for Disease Control and Prevention to incoming freshman at Princeton.

"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."

The designation of Breakthrough Therapy is intended to rush the development and review of new medicines and therapies that treat serious or life-threatening illnesses.

Meningitis B is rare but aggressive, and can kill or cause life-long disability within 24 hours. Symptoms can be flu-like and difficult to diagnose in early stages.