As Novartis seeks FDA approval to expand the approved treatment population for its quadravalent meningococcal conjugate vaccine Menveo to children ages 2 to 10, an untitled letter from the agency about the minimization of risk information in an audio news release for the product could drive the company to be more fastidious in any eventual launch of the expanded claims.

FDA sent the advertising letter, from CBER's Office of Compliance and Biologics Quality, on May 7, the same day that Novartis announced the agency had accepted for review an sBLA that would expand the vaccine's indication for 2-to-10-year-olds and another that would add data to labeling describing the persistence of meningococcal antibodies in adolescents 22 months after vaccination. Menveo is approved in the U.S. and EU for use in adolescents and adults ages 11 to 55 to help prevent disease caused by serogroups A, C, Y and W-135.

Both BLAs seem critical to Novartis' competitive strategy against Sanofi-Aventis' meningococcal vaccine Menactra , which is already approved for patients as young as 2 years old (Also see "Novartis Wins FDA Approval For Its First Meningitis Vaccine As ACIP Is Set To Meet" - Pink Sheet, 22 February, 2010.).

Warning and untitled letters for vaccine promotions are less common than those for drug promotions. One recent instance was CBER's May 2009 letter to MedImmune over newspaper reminder ads for its intranasal vaccine FluMist , which the agency said needed to contain risk information ('The Pink Sheet' DAILY, May 19, 2009).

Even though CBER sometimes seems less active than CDER on advertising enforcement, the letter will make Novartis keenly aware that FDA will likely be watching closely if it eventually rolls out the new label.

The untitled letter cites Novartis for an audio news release for Menveo, which "presents the efficacy claims for Menveo in a slow and deliberate manner that is understandable in terms of the pacing and articulation [whereas] the risk information is presented in a fast and inarticulate manner."

The risk information "is presented at a pace that does not allow the audience to hear and process it, which hinders the audience's comprehension of the risks presented," FDA added in the letter, which was posted online May 18.

The news release, which was connected with the February 2010 launch of the vaccine, had stopped airing by March 1, a company spokeswoman said.

FDA is looking out for the minimization of risk information in media releases, as in its October 2009 warning letter to King Pharmaceuticals for a media backgrounder for its opioid Embeda (morphine/naltrexone) (Also see "FDA Warns King Of Warning Letter: Firm Got Head Start On Fixing Embeda Ads" - Pink Sheet, 26 October, 2009.).

Theoretical Risk Of Omission

In Novartis' case, the problem may have been compounded by a print version of the news release, highlighting the idea that FDA can cite even a theoretical risk of omission of risk information.

The print version said that "'free hard copy of the 60-second audio news release [is] available on CD or as an MP3,'" but FDA said this is problematic in that "the efficacy claims take approximately one minute and 13 seconds with the risk information following for an additional 46 seconds. If the audio news release with a total play time of 1:59 is being presented as a 60-second piece, it is very possible that the risk information is actually omitted in its entirety."

Novartis attributed the discrepancy to "a clerical error by the vendor."

Menveo risks listed on the label include acute allergic reactions, including anaphylactic reactions; syncope, sometimes resulting in falling with injury or associated with tonic-clonic movements and other seizure-like activity; increased risk of Guillain-Barré Syndrome; unknown risks to immunocompromised persons; pain at the injection site, headache, myalgia, malaise and nausea.

- Martin Berman-Gorvine (m.berman-gorvine@elsevier.com) [Editor's note: This story has been updated to provide more information from Novartis and to correct a sentence which stated the company omitted, not minimized, risk information.]

FDA Letter On Menveo News Release Offers Cautions On Launch Of Expanded Indication

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