Pfizer’s vaccine candidate bivalent rLP2086 gains “Breakthrough” status

The US Food and Drug Administration has granted Breakthrough Therapy designation to pharma behemoth Pfizer’s (NYSE: PFE) vaccine candidate, bivalent rLP2086, currently under investigation for the prevention of invasive meningococcal disease due to Neisseria meningitidis serogroup B in people aged 10 to 25 years.

Breakthrough Therapy designation is intended to expedite the development and review of potential new medicines for serious and life-threatening diseases. This designation conveys the FDA's existing fast track development program features, as well as more intensive FDA guidance on an efficient drug development program.4

“Pfizer is developing this meningococcal B vaccine candidate to help protect adolescents and young adults against a difficult to diagnose and often deadly disease,” said Emilio Emini, senior vice president of vaccine R&D for Pfizer, adding: “We are encouraged by the FDA’s recognition of the need to prevent meningococcal B disease, and the Breakthrough Therapy designation highlights the urgent need for prevention of meningococcal B disease.”