Novartis Bexsero Bags Breakthrough Therapy Status by FDA

The United States Food and Drug Administration (FDA) has accorded a Breakthrough Therapy designation to Meningitis B vaccine Bexsero, manufactured by Swiss drug company Novartis. The company said after the new status for vaccine Bexsero, it plans to file for US approval of the vaccine this year itself.

Bexsero, which helps protect against meningococcal disease, has already got an approval in Europe, Canada and Australia. In the UK, Bexsero has already been included in the country’s National Immunisation Programme.

The Breakthrough Therapy designation will help in faster development and review of new medicines to treat serious conditions. Now, Novartis is the only firm to manufacture licensed vaccines for the five main serogroups that cause most of the cases across the globe.

After meningitis B outbreaks on campuses, in the past four months, Novartis has provided nearly 30,000 doses of Bexsero to students and staff at Princeton University and the University of California Santa Barbara (UCSB) as part of Investigational New Drug (IND) designation from the FDA.

“The recent outbreaks on US university campuses have shown that meningitis B is unpredictable and can strike at any time with devastating consequences. A US 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,” said Andrin Oswald, Division Head, Novartis Vaccines.

Meningitis B is disease that can kill or cause serious life-long disability within 24 hours of attack.

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Source-Medindia