Pfizer Inc (NYSE:PFE) has today made an announcement to inform all the concerned parties about the decision by the European Medicines Agency’s Committee for Medicinal Products for Human Use to grant marketing authorization in the European Union (EU) for active immunization of persons 10 years of age beyond towards the prevention of the invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB).3
Its positive opinion about the solution was quite noticeable in the recent past as revealed by some inside sources and now a lot of patients will be able to reap the benefits that come with taking up the high end form of medication.
The CHMP’s opinion will soon be making its way to the European Commission and of course this union will be entrusted with making the final decision.
It is quite a promising moment for persons over 10 years of age who have for a long time struggled with meningococcal disease caused by serogroup B, which happens to be a rare yet devastating and life-threatening complication. Of course this is after the positive opinion by CHMP in recommending the marketing authorization of TRUMENBA in the EU.
The senior vice president and head of Vaccine Research and Development for Pfizer Inc, Kathrin Jansen in a statement said that the recent decision was sure proof that indeed TRUMENBA bore a great effectiveness and at the same time showcased a robust safety profile.
Pfizer has lately been busy conducting a worldwide clinical development program for TRUMENBA, an undertaking that has had it evaluate more than 20,000 adults and adolescents. About 15,000 of them got to benefit from TRUMENBA.
CHMP reviewed the data and ended up saying that the drug showcased a wide range of benefits. It showed remarkable abilities to induce some protective serum bactericidal antibody responses to diverse meningococcal serogroup B strains expressing fHBP variants which are a perfect representation of the MenB strains that result in the numerous invasive diseases and asides from that it is also well tolerated.
Meningococcal disease strikes quickly and has no consideration for age. The new drug will be a great lifesaver if approved by the top body.