Eli Lilly to Withdraw Xigris due to Lack of Efficacy
Eli Lilly has decided to withdraw the product from the market worldwide due to lack of efficacy.
Eli Lilly has informed the European Medicines Agency that the company has decided to withdraw Xigris from the market worldwide further to the 28-day mortality results from the PROWESS-SHOCK study. Eli Lilly has also decided to discontinue all other ongoing clinical trials.
Xigris, which contains the active substance drotrecogin alfa (activated), was authorised in the European Union under exceptional circumstances in 2002 for the treatment of severe sepsis in adult patients with multiple organ failure, in addition to best standard care.
After the annual reassessment in 2007 the CHMP concluded that the initial efficacy results of the pivotal clinical study (the PROWESS study) had not been reproduced in further
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