Boston, MA 08/15/2014 (wallstreetpr) – Research-based global biopharmaceutical company, Pfizer Inc. (NYSE:PFE)’s vice president Emilio Emini termed the U.S. Food and Drug Administration or FDA acceptance of its Biologics License Application or BLA and the Priority Review designation as significant regulatory milestones.
FDA Accepts
The Pfizer Inc. (NYSE:PFE) disclosed that the drug regulator had accepted to review its BLA for its drug candidate, recombinant LP2086, for invasive meningococcal disease prevention caused by Neisseria meningitidis serogroup B among the age groups of 10 – 25 years. Another significant aspect was that the FDA had also given its nod for Priority Review designation for its BLA thus offering an expected Prescription Drug User Fee Act or PDUFA action slated for February 14 next year.
These developments have forced senior vice president of Pfizer’s Vaccine Research and Development Emilio Emini to term them as significant milestones highlighting its steps to accelerate the approval process and subsequent availability of its meningococcal B drug for the American adolescents.
Meningococcal Disease
An estimated 500K cases of meningococcal disease take place throughout the world every year due to Neisseria meningitidis. The company disclosed that bulk of the invasive meningococcal disease cases in the world has been attributed primarily to five serogroups of Neisseria meningitidis. Globally, approximately 20K – 80K cases were diagnosed due to Neisseria meningitidis serogroup B every year.
Pfizer Inc. (NYSE:PFE) pointed out the data of 2012 that indicated 40% of cases in the U.S. were attributed to serogroup B. The company also said that about 10% – 15% of patients affected by meningococcal disease had died despite the antibiotic treatment availability. Also 11% – 19% of the survived patients had to meet the fate of long-term disabilities like hearing loss, brain damage, limb amputations or learning disabilities. Currently, there was no approved medicine in the U.S. for meningococcal B disease.
About LP2086
Recombinant LP2086 is Pfizer Inc. (NYSE:PFE)’s investigational drug candidate for the treatment of meningococcal B disease that was composed of two recombinant antigens. The company was engaged in clinical development program globally for bivalent recombinant LP2086 that included Phase two and three studies evaluating over 20K patients. Its phase three program commenced in November 2012 through the initiation of a bigger scale safety study and more safety studies were being conducted.
