FDA Talks Heart Trials for Obesity Drugs

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Talk about an obese FDA advisory committee meeting. Starting tomorrow, the Endocrinologic and Metabolic Drugs Advisory Committee will spend two whole days discussing the need for clinical trials to determine heart risks for obesity drugs.

It seems ironic that this committee meeting comes 15 years after fen-phen was pulled off the market because of potential heart valve problems. For an agency that most investors would characterize as overly cautious, the FDA sure took its time. Of course, since then, heart data on Meridia, which Abbott Labs (NYSE: ABT  ) pulled off the market in the U.S., has come to light. And the FDA decided to require diabetes drugs to prove they weren't causing heart problems like GlaxoSmithKline's (NYSE: GSK  ) Avandia.

Approval decisions for VIVUS' (Nasdaq: VVUS  ) Qnexa and Arena Pharmaceuticals' (Nasdaq: ARNA  ) lorcaserin -- the second for both -- will come after the meeting, but the vote won't have a formal effect on the companies. It'll take awhile for the FDA to integrate the committee's opinion into some sort of official guidance for drugmakers. After waiting for so long, what's a few more months?

Indirectly though, what the advisors say, especially if they vote in favor of requiring a pre-approval trial, could weigh on the FDA's decisions about Qnexa and lorcaserin in the coming months.

I think it's likely we'll see a requirement that a heart trial be run for all obesity drugs. The only question is whether the trial needs to be run pre-approval or post-approval. VIVUS seems to be planning for that inevitability; at the advisory panel meeting for Qnexa, the biotech said it already has plans to run a post-approval trial.

If the advisory panel backs away from a requirement of a pre-approval trial, I'd be cautious about assuming the FDA will follow suit. Remember, the advisory panel said Orexigen's (Nasdaq: OREX  ) Contrave should be approved and asked to do a post-approval trial, but the agency overruled the advisory panel and turned down the drug until the company ran a large pre-approval trial.

The cost of development is essentially the same pre- or post-approval, but a post-approval requirement would clearly be better for companies because they could have revenue coming in while they wait for the heart data.

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Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. The Motley Fool owns shares of Abbott Laboratories. Motley Fool newsletter services have recommended buying shares of GlaxoSmithKline and Abbott Laboratories. The Motley Fool has a disclosure policy. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. Try any of our Foolish newsletter services free for 30 days.

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  • Report this Comment On March 27, 2012, at 4:16 PM, PhillyDan wrote:

    Lorcaserin did not have any CV signals in phase II or phase III studies. I think the panel will vote yes and post approval on question 3 on Thursday.

    Arena busy doing the meta analysis of phase II and III MACE. In addition, they will probably propose a similar CVOT post approval study.

    Arena key people can read very well and are two steps ahead of the FDA....

  • Report this Comment On March 28, 2012, at 7:17 AM, BiotechDJensen wrote:

    Below is a post from a yahoo blogger that I follow (he claims to be an MD from UCLA which from his previous posts, I believe to be true). My input in [ ] to help clarify - Dave


    With all due respect to certain longs and their concerns I think undue emphasis has been placed on the FDA’s EMDAC meeting [today's Panel] on Obesity with regard to Lorcaserin [ARNA's drug].

    First – the final Guidance will not be implemented in the near future.

    The formulation of a new guidance on MACE/CVOT trials [heart risk] for obesity drugs is extremely complex and will require a significant amount of time before finalized and accepted. This is a seminal meeting. To begin with there is no standard definition of MACE. Endpoints that reflect safety and effectiveness can lead to inconsistencies in interpretation and has lead experts to question whether use of MACE is of value, that is, is there validity and utility of MACE as a study endpoint. This is the conclusion of the Academic Research Consortium and remains current as of March 27, 2012. For an academic and objective academic review of this refer to “The Problem With Composite End Points in Cardiovascular Studies: The Story of Major Adverse Cardiac Events and Percutaneous Coronary Intervention.” Kevin Kip, PhD, et al. Journal of the American College of Cardiology, 2008.

    This meeting has the goal of setting the guidance for future anti-obesity medications because once lorcaserin and Qnexa get approved there will be a race to develop other anti-obesity drugs which as we all know is a huge market. All we have to do is to take a look at the diabetes market, drugs are being developed all the time – and once these two anti-obesity drugs are approved the road will become very crowded in the anti-obesity drug development field. In the worst case scenario, the results of this meeting may have an influence on the need for post approval MACE/CVOT studies.

    Second – the results of this meeting cannot be used to request pre or post approval studies because it will not be possible to set guidelines, endpoints, etc . if they have not yet been finalized.

    Third – the Adcomm meeting for Lorcaserin, and the PDUFA for that matter will be focused on the issues of the CRL [previous rejection letter]

    Arena performed large scale phase 3 studies of over 8000 patients of which there were no CV events in the lorcaserin study population. The FDA did not have single concern with MACE/CV events with regard to lorcaserin and this demonstrably evident in the content of the CRL. The Adcomm meeting should be, if the FDA follows it own protocols and procedures, discuss what was required of Arena in the CRL. They cannot impose a pre approval study on Arena regarding CV events for two reasons: there were no CV events in any of the 3 phase 3 trials, and second, you cannot request a MACE/CVOT study without having guidance in place. The Adcomm meeting’s purpose is to address the CRL issues and determine whether or not Arena answered all the concerns conclusively. LET US NOT FORGET THIS. If you look at the CRL the primary concern, admittedly unjustified, is, ‘Is there a mammary cancer and an astrocytoma cancer risk associated with the use of lorcaserin and is this risk translated to human risk.’

    I am in complete agreement with Jim Stevens (phillydan) in that this meeting has no bearing or influence on the Adcomm meeting or the acceptance of Lorcaserin. Lorcaserin will be accepted or rejected (which I seriously doubt) based on the results of Arena’s response to the CRL issues.

    Although, it is important to express our concerns, they should be based on what is known for certain rather than on what is conjecture, even if it is an honest attempt at reading between the lines. I disagree with the analysis given from the EMDAC meeting notes precisely for the reasons given above (though I highly esteem the one who presented the analysis).

    Keep this in focus: THE ADCOMM meeting May 10th was scheduled to discuss the CRL issues otherwise what would be the purpose to outline in detail items the FDA wanted Arena to address. The FDA, if nothing else, follows protocols and guidelines, so I cannot see them present new issues at the upcoming meeting. The EMDAC meeting on obesity guidance is preliminary, they have much work ahead of them and because of the immense importance of the obesity epidemic they will take as long as is necessary to complete it.


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