Pfizer, Novartis Compete with Separate BLA Submissions for Meningococcal B VaccineBy
In a bid to market the first meningococcal B vaccine in the US, Pfizer and Novartis separately submitted their biologics license applications (BLAs) for a meningococcal B vaccine to the US Food and Drug Administration (FDA).
Pfizer submitted a BLA to the FDA for bivalent recombinant LP2086 (rLP2086), the company's vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 to 25 year olds. Pfizer's investigational meningococcal B vaccine targets LP2086, or factor H binding protein, which is found on the surface of the meningococcal B bacterium. The gene for factor H binding protein is present in more than 1,800 meningococcal B isolates studied by Pfizer researchers. The vaccine contains two recombinant versions of the LP2086 antigen, one representative for each of the two known genetic subfamilies of the antigen.
Pfizer is conducting a global clinical development program for bivalent rLP2086, which includes both Phase II and Phase III trials evaluating more than 20,000 participants, approximately 14,000 of whom will receive the investigational vaccine. The Phase III program began in November 2012 with the initiation of a large-scale safety study. Additional immunogenicity and safety studies are also ongoing. The FDA granted breakthrough therapy designation for bivalent rLP2086 in March 2014 based, in part, on data from clinical trials studying the safety and immunogenicity of bivalent rLP2086.
Each year, approximately 500,000 cases of meningococcal disease occur worldwide due to N. meningitides.The majority of invasive meningococcal disease cases worldwide can be attributed to five serogroups (A, B, C, W-135, and Y). Disease caused by serogroup B has been estimated at between 20,000 and 80,000 cases per year globally. In 2012, approximately 40% of cases in the US were due to meningococcal disease caused by serogroup B. Despite the availability of antibiotic treatment, between 10% and 15% of patients with meningococcal disease die and 11% to 19% of those who survive are afflicted with long-term disabilities, such as brain damage, hearing loss, learning disabilities, or limb amputations. There is currently no meningococcal B vaccine approved for use in the United States.
Separately, Novartis submitted to the FDA a BLA for Bexsero (multicomponent meningococcal Group B Vaccine [recombinant, adsorbed]) to help protect against invasive meningococcal disease caused by serogroup B (meningitis B) in adolescents and young adults from 10 years through 25 years of age. This submission initiates a rolling submission process for Bexsero to the FDA, following the receipt of a breakthrough therapy designation in April 2014.
The vaccine is approved in 34 countries including across the European Union, Canada and Australia. Since the launch of Bexsero in 2013, over half a million doses have been distributed worldwide. In the US, Novartis provided nearly 30,000 doses of Bexsero to students and staff at Princeton University and the University of California Santa Barbara following meningitis B outbreaks on their campuses under an investigational new drug designation from the FDA. Further, the US Centers for Disease Control and Prevention have recommended including the incoming freshman class at Princeton University in the at-risk group to receive Bexsero.