EMA to review Pfizer’s meningococcal vaccine

pharmafile | May 20, 2016 | News story | Research and Development, Sales and Marketing |  EMA, Pfizer, meningitis, meningococcal vaccine, trumenba 

Pfizer (NYSE: PFE) has announced that the European Medicines Agency has accepting the marketing authorisation application for its meningococcal group B vaccine, Trumenba.

The vaccine has been developed for the prevention of invasive meningococcal disease, the most common cause of bacterial meningitis in the UK and Ireland, caused by meningitidis serogroup B in individuals aged 10 years and older.

This marketing authorisation application will rely on data from late stage trials which met the primary and secondary endpoints of strong immune responses. Trumenba is already currently approved for use in the US.

Kathrin Jansen, head of vaccine R&D at Pfizer, says: “The EMA’s acceptance of Trumenba’s marketing authorisation 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 serogrpup B.”

Sean Murray