EMA Accepts Pfizer's MAA for New Vaccine - Drug Discovery and Development

Pfizer Inc. today announced the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for Trumenb (Meningococcal Group B Vaccine) for review.

Trumenba has been developed for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B (MnB) in individuals aged 10 years and older.

In a statement the company said the acceptance marks the beginning of the regulatory review process for this vaccine 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,” said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development for Pfizer Inc.

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. Pfizer said the dataset demonstrates the consistency of vaccine-induced immune responses to diverse disease-causing MnB strains and the well-studied safety and tolerability profile. 1

Trumenba is currently approved in the U.S.