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FDA Grants Breakthrough Status Designation To Novartis AG (NVS)' Meningitis B Vaccine


4/8/2014 6:37:50 AM

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Novartis NVS +0.01% AG in Basel announced early this morning that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation – a rapid development track – for potential approval of Bexsero®, their innovative vaccine against type B meningococcal meningitis.

Bexsero® is a four-component vaccine (called 4CMenB) that’s currently approved in Europe, Canada and Australia. It was deployed last year for outbreaks at Princeton University and the University of California, Santa Barbara, under an Investigational New Drug application to combat meningitis B cases.

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