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Home Industry News Pfizer’s Trumenba receives CHMP backing for meningococcal group B disease

Pfizer’s Trumenba receives CHMP backing for meningococcal group B disease

29th March 2017

Pfizer's vaccine product Trumenba has been recommended for European regulatory approval for the prevention of meningococcal group B disease.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Trumenba for active immunisation of individuals ten years and older to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.

Trumenba has been evaluated in a clinical development programme including more than 20,000 adolescents and adults, approximately 15,000 of whom received Pfizer's vaccine.

This data showed that Trumenba's key benefits include its ability to induce protective serum bactericidal antibody responses to diverse meningococcal serogroup B strains expressing fHBP variants that cause invasive disease, as well as its well-tolerated performance.

Dr Kathrin Jansen, senior vice-president and head of vaccine research and development for Pfizer, said: "This positive opinion by the CHMP to recommend marketing authorisation of Trumenba in the EU is an additional step toward the fight to help protect individuals over ten years of age from meningococcal disease caused by serogroup B."

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