The US Food and Drug Administration (FDA) has awarded breakthrough therapy designation to Pfizer’s Trumenba for meningococcal B disease in children aged between one and nine.

Trumenba is being formulated as a vaccine to provide active immunisation to prevent meningococcal B. The disease is caused by Neisseria meningitidis group B (MenB), known to primarily affect adolescents and young adults in the US and Europe.

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In 2014, the drug candidate received breakthrough status for use in adolescents and young adults aged 10 to 25, and secured full approval in 2017 as a three-dose schedule.

The latest approval is based on safety and effectiveness data from Phase II clinical trials involving children older than one year.

“Despite the potential life-altering and long-term consequences that may result from this uncommon disease, there is no MenB vaccine licensed in the US for this age group.”

Pfizer scientific and clinical affairs, vaccines medical development chief medical and scientific affairs officer Dr Luis Jodar said: “Despite the occurrence of invasive serogroup B disease in children ages one through nine years, and the potential life-altering and long-term consequences that may result from this uncommon disease, there is no MenB vaccine licensed in the US for this age group.

“We look forward to working closely with the FDA toward our goal to extend the range of individuals who may benefit from immunisation with Trumenba.”

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The company also received marketing authorisation from the European Commission for the use of its drug Mylotarg (gemtuzumab ozogamicin) in combination with daunorubicin and cytarabine to treat acute myeloid leukaemia (AML).

This approval covers patients aged 15 and above suffering from previously untreated, de novo, CD33-positive AML, except acute promyelocytic leukemia.