Pfizer: EMA Accepts Trumenba's Marketing Authorization Application For Review

(RTTNews) - Drug maker Pfizer Inc. (PFE) said that the European Medicines Agency or EMA has accepted the Marketing Authorization Application for Trumenba or Meningococcal Group B Vaccine for review.

Trumenba has been developed for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B or MnB in individuals aged 10 years and older. The company noted that 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, senior vice president and head of Vaccine Research and Development for Pfizer.

Trumenba's Marketing Authorization Application or MAA is based upon a clinical trial dataset of about 20,800 adolescents and adults aged 10 years and older, studied globally.

The dataset demonstrated the consistency of vaccine-induced immune responses to diverse disease-causing MnB strains and the well-studied safety and tolerability profile.