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Meningitis B Vaccine Bexsero Receives ‘Breakthrough Therapy’ Designation

FDA submission expected in second quarter of 2014

Bexsero (meningococcal group B vaccine [rDNA, component, adsorbed], Novartis) has received a “breakthrough therapy” designation from the FDA.

The drug is already approved in Europe, Canada, and Australia to help protect against invasive meningococcal disease caused by serogroup B (meningitis B). Novartis plans to file for U.S. licensure of Bexsero as early as the second quarter of 2014; the timing will depend on guidance from the FDA.

During the last 4 months, Novartis has provided nearly 30,000 doses of Bexsero to students and staff at Princeton University and the University of California, Santa Barbara following meningitis B outbreaks on their campuses under an “investigational new drug” (IND) designation from the FDA. In addition, the Centers for Disease Control and Prevention (CDC) has recommended including the incoming freshman class at Princeton University in the at-risk group to receive Bexsero.

Meningitis B is the leading cause of bacterial meningitis and septicemia in the developed world. It can kill or cause serious life-long disability within 24 hours of onset. Because initial symptoms are often unspecific and flu-like, it can be difficult for even a health care professional to diagnose the disease in its early stages. About one in 10 of those with the disease will die despite appropriate treatment, and of those who survive, one in five will suffer from serious life-long disabilities, such as brain damage, hearing loss, or limb loss. Vaccination is therefore the best defense against the disease, which leaves little time for intervention.

With vaccines currently available in the U.S. to help prevent the other four most common serogroups that cause meningococcal disease (A, C, Y, and W), a licensed vaccine offering protection against serogroup B remains an unmet public health need in this country.

Source: Novartis; April 7, 2014.

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