Trumenba (vaccine) filed with EMA for Meningococcal Group B- Pfizer

The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for Trumenba (Meningococcal Group B Vaccine), from Pfizer, for review, in the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B (MnB) in individuals aged 10 years and older. The acceptance marks the beginning of the regulatory review process for this vaccine in the EU.

The MAA for Trumenba is based upon a clinical trial dataset of approximately 20,800 adolescents and adults aged 10 years and older, studied globally. This dataset demonstrates the consistency of vaccine-induced immune responses to diverse disease-causing MnB strains and the well-studied safety and tolerability profile. The drug is indicated in the US for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years of age.