European regulators have issued a green light for Nimenrix

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European regulators have issued a green light for UK drug giant GlaxoSmithKline’s Nimenrix, approving its use throughout the region for protection against specific bacteria causing meningococcal disease.

 

Specifically, the European Medicines Agency has given marketing authorisation for the conjugate vaccine to immunise individuals aged 12 months and above against invasive meningococcal disease caused by Neisseria meningitidis serotypes A, C, W-135 and Y.

 

Neisseria meningitidis is an easily transmitted disease with potentially disabling and, in the worse case scenario, even life-threatening consequences.

 

Estimates suggest that in the African meningitis belt, which houses around 300 million people, meningococcal disease can affect as many as 1000 in 100,000 in the dry season. In Europe incidence of the disease is much much lower at around 0.3 cases per 100,000.

 

While there are other vaccines on the market to protect against Neisseria meningitidis serotypes A, C, W-135 and Y, Nimenrix is the first quadrivalent vaccine to be approved in Europe for individuals from 12 months of age.

 

The jab comes in a single dose and was found in clinical trials – 17 in total involving more than 8,000 patients – to be well tolerated.

 

A spokeswoman for GSK told PharmaTimes UK News that the company is expecting the vaccine to be used in toddlers, adolescents and adults who may be travelling to meningitis-endemic regions.

 

“It can also be incorporated in to child immunisation programmes in those European countries where local guidelines recommend vaccination to help protect against meningitis, as well as being used through private access in markets where there are no universal mass immunisation programmes,” she added.

 

While pricing information will remain under wraps until all negotiations with member states are complete, “GSK will make Nimenrix available at preferential prices to developing countries using a tiered pricing system,” the spokeswoman confirmed.

Source:
Online Pharma Times

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