BASEL (dpa-AFX) - Novartis International AG (NVS) Monday said its Bexsero, a Meningococcal Group B Vaccine has received Breakthrough Therapy designation from the United States Food and Drug Administration or FDA.
Meningitis B is the cause of bacterial meningitis and septicemia and a licensed vaccine offering protection against serogroup B remains an unmet public health need in the US, said the FDA. The Breakthrough Therapy designation will expedite the development and review of new medicines that treat serious or life-threatening conditions. This designation includes all of the fast track program features, as well as more intensive FDA guidance.
Novartis currently is the only company with licensed vaccines for all five main serogroups that together cause the majority of cases in the world. Bexsero is a protective vaccine against invasive meningococcal disease caused by serogroup B and has already been approved in Europe, Canada and Australia.
The company said it plans to file for US licensure of Bexsero as early as in the second quarter of 2014.
Copyright RTT News/dpa-AFX