12:00 AM
Feb 16, 2004
 |  BioCentury  |  Product Development

Removing the death mask

It can be virtually impossible to get a drug approved in a disease when there is a high underlying rate of mortality due to multiple causes unrelated to the targeted condition. IntraBiotics Pharmaceuticals Inc. believes that its participation in a new FDA program that effectively makes the agency a partner in the company's development effort, as well as its Special Protocol Assessment with FDA, enhance its prospects for being the first to address this challenge in the ICU setting.

IBPI's iseganan is being developed to prevent the most common infection in patients on life support: ventilator-associated pneumonia. While FDA is not about to ignore mortality, it has agreed to another primary endpoint, VAP among survivors.

Most importantly, IBPI says that showing VAP among survivors in two trials will be enough for approval, as long as the mortality numbers don't show anything unexpected. Thus, there is no requirement that IBPI show a mortality benefit.

"The issue arises in settings in which mortality is not the primary expected measure of benefit, but in which mortality occurs at a frequency that's comparable to the event that you're trying to treat or prevent," noted Henry Fuchs, president and CEO of...

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