FDA chides Novartis on meningitis vaccine promotion

FDA chides Novartis on meningitis vaccine promotion

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WASHINGTON (Global Markets) - Novartis AG falsely implied that its Menveo meningitis vaccine was approved in a manner consistent with guidelines from an influential U.S. advisory group, health regulators said in a letter to the Swiss drugmaker.

The U.S. Food and Drug Administration in the letter dated June 24 and released on Friday said some statements in a recorded phone call and professional slides from March were "false and misleading."

The FDA also said the promotional materials falsely imply that FDA-approved use of Menveo is consistent with published recommendations by the U.S. Advisory Committee on Immunization Practices, a panel of federal vaccine experts that advises the U.S. Centers for Disease Control and Prevention.

The FDA requested that Novartis immediately stop using such promotional material and the company's spokeswoman said the vaccine unit has already done that.

"(The unit) takes this communication very seriously and has immediately ceased the dissemination of the material in question," said spokeswoman Brandi Robinson. "We are committed to addressing the FDA's concerns adequately and expeditiously."

Earlier this month, the FDA accepted Novartis's application to broaden the use of Menveo in infants and toddlers from 2 months of age. The vaccine, which protects against strains of the meningococcal disease that causes potentially deadly meningitis, is approved in the United States for people aged between 2 and 55.

Novartis has three types of meningitis vaccines, and it is optimistic that its meningitis franchise will be a blockbuster. The company is also hoping its meningitis franchise will help the unit reduce its dependency on sales from pandemic vaccines.

The FDA posted the warning letter here: here

(Reporting by Alina Selyukh. Editing by Robert MacMillan, Bernard Orr)