UPDATE 1-Novartis to file meningitis vaccine for infants

* Study shows Menveo immunises infants from 2 months of age

* Highest rate of infections occurs in first year of life

(adds details, background)

ZURICH, Oct 25 (BestGrowthStock) – Swiss drugmaker Novartis AG
(NOVN.VX: ) wants to file its meningitis vaccine Menveo for use in
small infants in the United States and Europe after a late-stage
study with children of this age group was successful.

In the phase III study, a high percentage of the 4,500
infants as young as 2 months showed the immune response when
given Menveo, Novartis said. The vaccine was well tolerated,
with a safety profile similar to routine infant vaccines.

The vaccine would help to immunize infants at an age when
the highest rates of the meningococcal disease — a sudden,
serious and often deadly disease — occur, Novartis said.

Based on the study, Novartis now plans to file for an
application of a broader use of the vaccine with the U.S. Food
and Drug Administration (FDA). The label extension claim will
also be submitted in Europe and elsewhere, the drugmaker said.

Menveo is approved in the U.S., Europe and a series of other
countries for active immunization to prevent invasive
meningococcal disease — a leading cause of bacterial meningitis
— in individuals 11 years and older.

Novartis plans to submit additional data to the European
Medicines Agency to support the use of Menveo in infants from
two months to two years old, as well as in children from two to
10. An extension for the use of Menveo in children from two to
10 is currently under review by the FDA.
(Reporting by Sven Egenter; Editing by Will Waterman)

UPDATE 1-Novartis to file meningitis vaccine for infants