ARTICLE | Clinical News

Bexsero regulatory update

February 2, 2015 8:00 AM UTC

FDA granted accelerated approval to Bexsero from Novartis to vaccinate against invasive meningococcal disease caused by serogroup B in people ages 10-25. The intramuscular multicomponent meningococcal serogroup B vaccine has breakthrough therapy status in the U.S. and had been available under a treatment IND in the U.S. as part of vaccination programs at 2 universities. Bexsero is slated to launch this quarter; Novartis will announce a price this month. The vaccine is given twice at least a month apart. ...