Pfizer Receives Breakthrough Therapy Designation for Meningococcal B Vaccine Candidate - - BioPharm International

ADVERTISEMENT

Pfizer Receives Breakthrough Therapy Designation for Meningococcal B Vaccine Candidate


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

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Suppliers Seek to Boost Single-Use Technology
August 21, 2014
Bristol-Myers Squibb and Celgene Collaborate on Immunotherapy and Chemotherapy Combination Regimen
August 20, 2014
USP Center in Ghana Receives International Lab Accreditation
August 15, 2014
USP Awards Analytical Research
August 15, 2014
FDA Warns about Fraudulent Ebola Treatments
August 15, 2014
Author Guidelines

Click here