Bloomberg News

EMA Weighing J&J’s Doribax Antibiotic After Trial Halted in U.S.

January 08, 2012

Jan. 6 (Bloomberg) -- The European Medicines Agency said it’s looking at the results of a terminated U.S. trial of Johnson & Johnson’s Doribax antibiotic, which is approved in Europe to treat pneumonia.

“We are aware of the termination of the study and are looking at whether this has an impact on the benefit-risk balance of the approved indication,” the London-based agency said today in an e-mailed statement.

The New Brunswick, New Jersey-based company halted the trial of Doribax after more pneumonia patients who took the product died and fewer were cured, the U.S. Food and Drug Administration said yesterday. The trial tested the drug in pneumonia patients who were on ventilators, a use that’s approved in the European Union.

To contact the reporter on this story: Makiko Kitamura in London at mkitamura1@bloomberg.net

To contact the editor responsible for this story: Kristen Hallam at khallam@bloomberg.net


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