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

AbbVie to Acquire Shire for $54.7 Billion
July 18, 2014
AstraZeneca Reveals Design for New Global R&D Center and Corporate Headquarters
July 18, 2014
Particulate Matter Prompts Baxter's Recall of IV Solutions
July 17, 2014
Mylan to Acquire Abbott's Non-US Businesses in $5.3 Billion Stock Deal
July 14, 2014
Shire and AbbVie Discuss Possible Deal
July 14, 2014
Author Guidelines

Click here