GlaxoSmithKline receives CHMP backing for Nimenrix

GlaxoSmithKline's Nimenrix has been granted a recommendation for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

The committee has endorsed the company's application for marketing authorisation of the new treatment for use in active immunisation against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y.

This highly contagious disease is most prevalent in the African meningitis belt and can be easily transmitted with often fatal consequences, affecting up to 1,000 people per 100,000 members of the population during the dry season.

Immunogenicity and safety data from more than 8,000 patients was assessed by the CHMP as part of its review, which is one of the final steps in the regulatory assessment process.

Thomas Breuer, senior vice-president and head of global vaccine development at GlaxoSmithKline, said: "This positive opinion represents a major milestone in our development programme and we look forward to receiving the final decision from the European Medicines Agency in the coming months."

Last week, it was announced that GlaxoSmithKline will also be applying for European approval of its breast cancer treatment Tyverb in a new indication, based on positive recent clinical data.