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J&J halts study of antibiotic Doribax after patient deaths

Not clear what the implications will be for the carbapenem antibiotic’s EU registration

Johnson & Johnson (J&J) has stopped a clinical trial of its carbapenem antibiotic Doribax after an interim analysis revealed patients on the drug were more likely to die than those on a comparator treatment.

The study of 274 patients with ventilator-associated pneumonia found that 21.5 per cent of those treated with Doribax (doripenem) had died within 28 days of starting treatment, compared to 14.8 per cent of those treated with a combination of imipenem and cilastatin.

Moreover, clinical cure rates were also lower with J&J's drug, at 45.6 per cent versus 56.8 per cent for the comparator regimen.

Doribax has been on the US market since 2007 as a treatment for intra-abdominal and urinary tract infections, and is still considered safe for this indication, according to a notice on the US FDA website.

The trial has implications for the product in Europe, however, as it has already been approved by the EMA as a treatment for hospital-acquired pneumonia, including pneumonia occurring in patients on ventilators.

J&J carried out the trial as part of a commitment to the EMA to carry out post-marketing assessments of Doribax, and at present it is not clear what the implications will be for Doribax's EU registration.

The company filed for US approval of Doribax in hospital-acquired pneumonia in 2007, but while this indication was narrowly backed by an FDA advisory committee in 2008, the US regulator asked for additional information before it would consider approval in this clinical setting.

Commercially, the decision has only a modest impact on J&J. Doribax is a relatively minor product for the company, and does not feature in the list of key brands in its financial breakdowns.

Clinically the impact is greater, however, as there was hope that Doribax would add to the clinical armamentarium for ventilator-associated pneumonia. The infection has a high mortality rate (33 to 50 per cent) and extends hospital stays by a week or more, draining healthcare resources.

9th January 2012

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