Drotrecogin alfa (activated) ... a sad final fizzle to a roller-coaster party
Prompted by the failure of PROWESS Shock to demonstrate efficacy, Eli Lilly and Co withdrew drotrecogin alfa (activated) from the worldwide market. Drotrecogin was initially approved after the original trial, PROWESS, was stopped early for overwhelming efficacy.
These events prompt consideration of both the initial approval decision and this latest decision to withdraw. It is regrettable that the initial decision was made largely on a single trial that was stopped early.
However, the decision to approve was within the bounds of normal regulatory practice and was made by many approval bodies around the world. Furthermore, the overall rate of approvals followed by subsequent withdrawals remains very low.
The decision to withdraw was a voluntary decision by Eli Lilly, and likely reflected key business considerations. Drotrecogin does have important biologic effects, and it is probable that we do not know how best to select patients that would benefit.
Overall, even used non-selectively, there may still be a small advantage to drotrecogin alfa, but the costs of determining such an effect with adequate certainty are likely prohibitive, and the point is now moot. In the future, we should consider ways to make clinical trials easier and quicker, such that more information can be available in a timely manner when considering regulatory approval.
At the same time, more sophisticated patient selection seems key if we are to most wisely test agents designed to manipulate the septic host response.
Author: Derek C Angus
Credits/Source: Critical Care 2012, 16:107
Published on: 2012-02-06
Copyright by the authors listed above - made available via BioMedCentral (Open Access). Please
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