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GSK submits more data on MenHibrix to FDA

Files additional information in a bid to get the marketing application for its meningitis vaccine back on track

GlaxoSmithKline has filed additional information requested by the US Food and Drug Administration (FDA) for its meningitis vaccine MenHibrix in a bid to get its marketing application for the product back on track.

MenHibrix is an investigational combination vaccine for early protection against Haemophilus influenzae type b (Hib) and meningococcal disease caused by the C and Y strains, and was fast-tracked by the FDA when it was filed in 2009.

Since then, the agency has sent GSK two Complete Response letters, most recently in September, asking for additional information before it could deliver a verdict on approval.

MenHibrix could be an important new option in the fight against meningococcal disease, which can cause permanent disability or death with a fatality rate of 9 to 12 per cent.

GSK is trying to get approval for its use as active immunisation of infants and toddlers aged from six weeks to 15 months, "where the need for effective protection is greatest", according to the company.

Adding in the Hib component covers another common cause of meningitis.

Sanofi Pasteur's rival Menactra vaccine covers meningitis strains A, C, W-135 and Y, but is indicated for patients aged nine months and older. Meanwhile, Novartis' Menveo protects against the same strains as Sanofi's product but is indicated for use in those aged two years or over. 

Earlier this year, the FDA blocked an application to lower the earliest approved age to two months, forcing Novartis to resubmit the dossier.

The US Centers for Disease Control and Prevention (CDC) has been debating for some time the value of adding a meningococcal vaccine into the routine immunisation schedule for infants and toddlers.

In October, its Advisory Committee on Immunisation Practices backed the use of Menactra from nine months. If GSK can secure approval for MenHibrix and the CDC backs earlier vaccination, the company could leapfrog Menactra by providing an earlier first shot, with boosters required at four, six and 12-15 months.

Menactra sales were $436m last year, while analyst estimates for peak sales of the vaccines tend to fall in the $500m to $1bn range.

The nature of the FDA's information request has not been disclosed. In a short statement, GSK said it will "continue to work closely with FDA as the agency continues its review".

2nd December 2011

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