Pfizer files BLA at FDA for LP2086 vaccine for the prevention of invasive Meningococcal Disease.
Pfizer Inc. announced that the FDA has accepted for review the Biologics License Application (BLA) 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 through 25 year olds.
The FDA has also granted Priority Review designation for the BLA, providing an anticipated Prescription Drug User Fee Act (PDUFA) action date of February 14, 2015.
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.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.