* Menveo protects against a cause of meningitis
* Novartis seeking approval in infants and toddlers
* Menveo already approved for people 2-55 years
(Adds details, background)
ZURICH, June 16 U.S. authorities have accepted
Novartis's application to broaden use of its meningitis vaccine
Menveo, the Swiss drugmaker said on Thursday, giving its
Vaccines and Diagnostics unit another boost.
Menveo, which protects against strains of the meningococcal
disease, a cause of potentially deadly meningitis, is already
approved in the United States for people aged between two and
Now the Basel-based drugmaker is also seeking to use it in
infants and toddlers from 2 months of age.
Novartis's supplemental Biologics License Application (sBLA)
is supported by data from pivotal trials that included more than
6,000 infants and toddlers worldwide, Novartis said.
The vaccine was generally well tolerated when administered
alone or with other paediatric vaccines, the group said.
Meningitis is an inflammation of the lining around the brain
and spinal cord, and can kill within hours. The illness has a
high incidence rate among infants and can leave them
brain-damaged, deaf or with learning difficulties.
Earlier this month, Novartis said its Bexsero vaccine helped
protect toddlers against the most common cause of meningitis
when used as a booster. [ID:nLDE7571WN]
The Vaccines & Diagnostics unit, Novartis's smallest, has
three types of meningitis vaccines, and it is hopeful its
meningitis franchise will be a blockbuster.
(Reporting by Katie Reid; Editing by Will Waterman)