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Drotrecogin alfa (activated), Xigris, was licensed in 2001 by the Food and Drug Administration (FDA) and in 2002 by the European Medicine Agency (EMA) for the treatment of severe sepsis and septic shock. The FDA approval process was marked by conflicting opinions during the Anti-Infective Drugs Advisory Committee meeting, where many concerns with regard to the Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) trial, the study on which the approval was based, were raised.1 In the attempt to follow some of the criticisms, the approval was restricted to a subgroup of the study population that was not predefined, so violating well-known methodological rules and guidelines established by the FDA itself.2 The EMA approved the drug following a similar biased approach. Both regulatory agencies recognised efficacy and safety issues the drug increased the number of severe bleedings, and required post-marketing studies to support the licensing. These studies failed in confirming the first positive results,3 4 but their findings were …
Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests DP has no conflict of interest. GB was a member of the European Medicines Agency (EMEA) Ad Hoc Expert Group for the second annual reassessment of DrotAA. SG was a member of the EMEA Committee for Medicinal Products for Human Use (CHMP) from 1997 to 2004.
Provenance and peer review Commissioned; internally peer reviewed.