The FDA has reported that 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. Doribax is currently approved in the United States to treat adults with complicated urinary tract or abdominal infections. It’s not approved by the FDA for any type of pneumonia. In a clinical trial, testing Doribax on patients with ventilator-associated pneumonia, those who received the drug had a 6.7% higher rate of death from any cause than patients getting an alternative.
Patients taking Doribax also had an 11.2% 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. The trial was conducted as part of a post-marketing requirement from the European Medicines Agency, according to a spokesman at Janssen, the J&J unit that markets the drug. Japanese drugmaker Shionogi & Co. manufactures Doribax.
The trial, which had study sites in several countries, including the United States, was halted in May 2011. This was said to have been based on the recommendation of an independent data monitoring committee. The company says it has now finished analyzing the results. In the halted trial, the 28-day all-cause mortality rate was 21.5% for those who received Doribax, compared with 14.8% in the control group. The Janssen spokesman claims that Doribax was 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. In August 2008, the FDA asked the company for more information. The company says it resubmitted its application and is still in discussions with the FDA.
Source: Claims Journal
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