FDA Says J & J Halted Doribax Trial Due to Safety Issues

By Anna Yukhananov | January 6, 2012

Johnson & Johnson shut down a clinical trial of its antibiotic Doribax for a type of pneumonia after patients taking the drug had higher rates of death and a lower cure rate than those who got an alternative medicine, U.S. health regulators said on Thursday.

Doribax is currently approved in the United States to treat adults with complicated urinary tract or abdominal infections but not for any type of pneumonia, the Food and Drug Administration said.

In a clinical trial testing Doribax on patients with ventilator-associated pneumonia, those who received the drug had a 6.7 percent higher rate of death from any cause than patients getting an alternative.

Patients taking Doribax also had a 11.2 percent lower rate of being cured than patients getting imipenem-cilastatin, the generic version of Merck & Co Inc’s Primaxin.

Doribax, known generically as doripenem, is approved for hospital-acquired pneumonia in Europe, and the trial was conducted as part of a post-marketing requirement from the European Medicines Agency, said Shaun Mickus, spokesman at Janssen, the J&J unit that markets the drug.

Japanese drugmaker Shionogi & Co manufactures Doribax.

Mickus said the trial had study sites in several countries, including the United States.

The trial was halted in May 2011 based on the recommendation of an independent data monitoring committee, and the company finished analyzing the results recently.

In the halted trial, the 28-day all cause mortality rate was 21.5 percent for those who received Doribax compared with 14.8 percent in the control group.

Mickus said Doribax was still safe and effective for its approved uses in the United States.

In June 2007, Johnson & Johnson applied for U.S. approval of Doribax for the treatment of pneumonia acquired in the hospital, known as nosocomial pneumonia, which includes ventilator-associated pneumonia.

The FDA asked the company for more information in August 2008, and Mickus said the company had resubmitted its application and was still in discussions with the agency.

(Reporting by Anna Yukhananov, additional reporting by Bill Berkrot; editing by Andre Grenon)

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