Queen City of the Gold Rush

Boon or Bane? The FDA Cardiovascular Safety Hurdle

Almost ten years ago, FDA set a new hurdle for approving new diabetes drugs. Before one of these new drugs could be approved, the sponsoring company would need an expensive cardiovascular safety study. How expensive? The price tag might run as high as a billion dollars.

FDA laid this same requirement on new obesity drugs, too.

In Response to a Drug Safety Crisis

This big safety study requirement grew out of the Avandia debacle. A 2007 meta-analysis in the New England Journal of Medicine by Steven Nissen and Kathy Wolski linked Avandia (rosiglitazone) to heart attacks and cardiovascular deaths. At the time, Avandia was a blockbuster diabetes drug.

FDA never forced a withdrawal of Avandia. But FDA imposed restrictions that all but killed the product. Along the way, GSK faced investigations for downplaying safety data. And the company wound up paying a $3 billion fine. It was a hot mess, to say the least.

Out of that mess came the requirement for cardiovascular safety studies on all new diabetes and obesity drugs.

A Double-Edged Sword

On one hand, the requirement for these outcome studies represents a barrier to innovation. A new analysis in Clinical Pharmacology and Therapeutics finds a 31% drop in new diabetes drugs entering phase II clinical studies.

On the other hand, the study found that the drugs going into those trials were likely to be more innovative. Many more of them targeted unique biological mechanisms. Also, notably, all of the current crop of new obesity drugs approvals came after this new requirement.

And finally, this requirement for cardiovascular outcome studies can boost the fortunes of drugs that get especially good results. Recently empagliflozin (Jardiance) received FDA approval for an indication to prevent heart attacks and death in diabetes patients. Victoza (liraglutide) is awaiting a similar indication.

But the biggest home run – from our perspective – would be to find a new obesity drug that cuts premature deaths. A billion-dollar hurdle for innovation is indeed steep. But such a breakthrough would be well worth it.

Click here for the study in CP&T and here for another perspective from Forbes. If you want to read more of the Avandia saga, click here.

Queen City of the Gold Rush, photograph © Base Camp Baker / flickr

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July 29, 2017

2 Responses to “Boon or Bane? The FDA Cardiovascular Safety Hurdle”

  1. July 29, 2017 at 12:16 pm, Angela Meadows said:

    Weight-loss medications have an ignomious history – with a trail of drugs bursting onto the scene as The Solution only to be withdrawn later amid reports of severe and even fatal side effects. Some of the people taking those drugs may have had no metabolic illness beyond their actual size, and even if they did, death is not a good alternative. That should be reason enough.

    • July 29, 2017 at 12:21 pm, Ted said:

      Thank you Angela. I understand your comments as support for the value of carefully studying studying cardiovascular outcomes.