FDA Approves Breakthrough Therapy Designation for Meningitis B Drug, Bexsero

Novartis, the worldwide provider of healthcare solutions, recently submitted Bexsero to the U.S. Food and Drug Administration for approval. The new meningitis B drug has impressed the FDA and could be approved soon.

The FDA has granted Bexsero Breakthrough Therapy (BT) designation, which is intended to expedite the development and review of drugs for serious or life-threatening conditions. Meningitis B is a very serious disease that kills one in every ten people that is diagnosed with it.

Bexsero is a four-component vaccine (4CMenB) that prevents a specific form of meningitis bacterium called Neisseria meningitides, which is not protected against in current vaccines in the United States. Last year, it was deployed to the U.S. to manage meningitis B outbreaks at Princeton University and the University of California, Santa Barbara.

Bexsero was approved in Europe, Canada, and Australia, and soon to be the United States. With the FDA's Breakthrough Therapy designation, Novartis believes they will soon be able to file a New Drug Application soon in order to market the vaccine prior to the 2014-2015 school year.

Current vaccines protect against meningococcal diseases caused by groups A, C, W-135, and Y. The U.S., Europe, Canada, and Australia experience the highest rates of the meningococcal serogroup B, which can either result in death within 24 hours or cause life-long disabilities. One of the students who contracted the disease at UC Santa Barbara had both of his feet amputated.

Now finally, after 20 years of research, the development of Bexsero has been found to protect against meningitis B, especially among the vulnerable age groups, specifically infants, who have the greatest risk of being infected. It can be administered in children as young as two months old and it has a similar administration routine as other vaccines. With all of the positive information laid out in front of them, maybe the FDA can make the right decision soon.

To read more about Bexsero and the FDA-approval process, visit this Novartis profile of Bexsero.