The drugmaker is seeking FDA expanded use of its Doribax antibiotic to treat pneumonia for patients on mechanical ventilators, for which no drug is currently approved. However, FDA reviewers indicate they have several reservations, according tobriefing documents posted prior to an advisory committee meeting to be held in two days.
"Review of case report forms and the database revealed several major concerns that limit the ability to evaluate the efficacy of doripenem in this study," the FDA reviewers wrote (please see page 33). The FDA questioned J&J's interpretation of chest radiographs in studies submitted to the agency, saying many patients lacked " convincing" evidence of pneumonia. To be included in the study, patients had to show evidence of having infiltrates consistent with pneumonia.
J&J told the FDA about 6 percent of patients studied didn't meet strict radiologic criteria for pneumonia. Doribax, by the way, has already been approved by the FDA to treat complicated urinary tract and intra-abdominal infections.
Hat tip to Dow Jones