May 20, 2016
Pfizer Inc. has announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for TRUMENBA® (Meningococcal Group B Vaccine) for review. This TRUMENBA has been developed for preventing invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B (MnB) in individuals aged 10 years and older. This acceptance of this vaccine can be considered as the beginning of the regulatory review process in the EU.
“The EMA’s acceptance of TRUMENBA’s Marketing Authorization Application brings us one step closer to fighting this uncommon yet life-threatening disease worldwide, by helping to protect adolescents and adults who are at risk to contract meningococcal disease caused by serogroup B. At Pfizer we are committed to providing innovative vaccines that help people live the longest, healthiest lives possible,” said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development for Pfizer Inc.
This MAA for TRUMENBA is based on a clinical trial dataset of nearly 20,800 adolescents and adults aged 10 years and older, which was studied at the global level. This dataset reveals the consistency of immune responses induced by vaccine to diverse disease-causing MnB strains and the well-studied tolerability and safety profile.