Pfizer Receives Breakthrough Therapy Designation for Meningococcal B Vaccine Candidate

Mar 25, 2014
By PharmTech Editors

FDA granted breakthrough therapy designation to Pfizer’s vaccine candidate, bivalent rLP2086, which is currently under investigation for the prevention of invasive meningococcal disease due to Neisseria meningitidis serogroup B in persons 10–25 years of age. Disease caused by Neisseria meningitidis serogroup B has been estimated at between 20,000 and 80,000 cases per year globally and can result in death or significant long-term disabilities, including brain damage and hearing loss, Pfizer noted in the press release.

Pfizer is conducting a global clinical development program for rLP2086, which includes both Phase 2 and Phase 3 trials evaluating more than 20,000 participants, about 14,000 of whom will receive the investigational vaccine, according to the press release. Pfizer intends to submit a Biologics License Application (BLA) to FDA for bivalent rLP2086 by mid-2014.

Source: Pfizer