Please login to the form below

Not currently logged in
Email:
Password:

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

Share

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
An agency called Owen

We’re a Healthcare Communications Agency specialising in Multi-channel Marketing to make you Digitally Fitter, Stronger & Faster....

Latest intelligence

JulAug cover image
The Chronicles of Pharma: a creative review of pharma’s journey to omnichannel
Chris Ross conducts a literary-inspired review of pharma’s pursuit of communications excellence...
The key to psoriasis innovation? Dispelling the shadow of the JAK inhibitor
Powerful therapies that can improve skin clarity dominate the psoriasis landscape, so why are most patients stuck in a cycle of ineffective topicals? Fishawack Health explores the market and reveals...
Virtual Speaker Program: A Customer Story
Learn how we helped our client develop a virtual speaker program and roll out a series of regional peer-to-peer education sessions....