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Pfizer wins EU approval for MenB vaccine Trumenba

US pharma firm’s injection can now be given to patients aged 10 and above

Pfizer

Pfizer's Trumenba has been approved for the prevention of meningitis B (MenB) in Europe, laying the ground for the first alternative to GlaxoSmithKline's Bexsero, supplies of which have been held back by production constraints.

The EU approval comes two-and-a-half years after Trumenba was green-lighted by the US FDA to prevent invasive meningococcal disease caused by Neisseria meningitides serogroup B, which is estimated to account for around a third of reported cases of meningitis.

Trumenba has been approved in Europe to prevent MenB in people aged 10 or above, more than four years after Bexsero first got the nod from the EMA. Since then - and despite supply problems - Bexsero has grown into a major driver for GSK's vaccines business with sales more than doubling to reach £390m (around $500m) last year.

The vaccine continued its upwards trajectory in the first three months of this year bringing in £126m, but while GSK has said it is continuing to invest in manufacturing capacity for the vaccine it concedes this is a "long cycle process and supply is likely to remain tight for some time". The company is building a new plant in Germany to make some of the components of Bexsero but this is not scheduled to come online until 2020.

EU approval gives Pfizer an opportunity to kick-start sales of Trumenba, which was lumped into the 'other vaccines' category in Pfizer's 2016 report with collective sales of $67m.

The US big pharma group played up the lack of supply constraints in its statement on the EU approval, saying it is "focused on consistent, reliable supply for all the vaccines we manufacture, including a full 36-month shelf life with Trumenba". Bexsero has the advantage of being approved for use in children aged from two months.

The UK-based Meningitis Research Foundation said it welcomed the licensing of Trumenba, with chief executive Vinny Smith saying that having a second option is "another positive step forward".

"It means that it will likely only be a matter of months before the vaccine can go on sale in Europe," he continued. "It is important to have multiple tools at our disposal to combat this disease and time will tell how each vaccine can play its part in helping us to defeat MenB."

Article by
Phil Taylor

31st May 2017

From: Regulatory

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