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UPDATE 1-FDA accepts Novartis broader Menveo use application
June 16, 2011 / 6:49 AM / in 6 years

UPDATE 1-FDA accepts Novartis broader Menveo use application

* 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 (Reuters) - 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 55.

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)

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