Pfizer Gets European Regulator Acceptance For Review Of Marketing For TRUMENBA

Pfizer Inc PFE disclosed that the European Medicines Agency has accepted its Marketing Authorization Application (MAA) for its TRUMENBA for review. According to the company, the drug was developed to prevent invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B (MnB) in individuals aged 10 years and above.

Pfizer said that the acceptance marked the beginning of the regulatory review process for this vaccine in the European Union.

Its SVP and Head of Vaccine R&D, Kathrin Jansen, commented about the decision, "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. At Pfizer we are committed to providing innovative vaccines that help people live the longest, healthiest lives possible."

Pfizer said that the MAA for TRUMENBA was based upon a clinical trial dataset of about 20,800 adolescents, as well as adults aged 10 years and older, studied globally. The company added that this dataset demonstrated the consistency of vaccine-induced immune responses to diverse disease-causing MnB strains and the well-studied safety and tolerability profile.

The drug maker said that vaccines were one of the greatest public health advances, illustrating control, elimination or near-elimination of a number of infectious and vaccine-preventable diseases. The company's portfolio was built with vaccines that help protect against five of the most common serogroups creating invasive meningococcal disease (A, B, C, W and Y).

As far as the America is concerned, the pharmaceutical firm said that TRUMENBA was approved. The company cautioned that it should not be given to anyone with allergic reaction history after an earlier dose. In 2014, TRUMENBA was reviewed and received Accelerated Approval from the FDA's Breakthrough Therapy designation and Priority Review programs.